Job Postings
AMDM posts open positions within the IVD Industry.
The is no charge for AMDM Members for a 60-day posting. Non-members are charged $150 (Pay via our secure online store).
AMDM members are notified via email when a new posting is uploaded.
To post your open position, please send your job description (be sure to include how to apply for the position) and contact information to amdm_secretary@att.net. Jobs will be published on this page within 48 hours and a notice sent to the AMDM membership alerting them to the new posting.
The is no charge for AMDM Members for a 60-day posting. Non-members are charged $150 (Pay via our secure online store).
AMDM members are notified via email when a new posting is uploaded.
To post your open position, please send your job description (be sure to include how to apply for the position) and contact information to amdm_secretary@att.net. Jobs will be published on this page within 48 hours and a notice sent to the AMDM membership alerting them to the new posting.
Posted Date: 4/6/2022
Position Title: Senior Regulatory Affairs Specialist, Inflammatix
Inflammatix is seeking a Senior Regulatory Affairs Specialist to collaborate on multiple submissions in a nascent Regulatory Affairs team. This position reports to the Head of Regulatory Affairs. The Senior Regulatory Affairs Specialist contributes to establishing global regulatory strategy in collaboration with cross functional stakeholders and is responsible for timely execution of the strategy for new and existing products to ensure compliance with global regulatory requirements.
POSITION SUMMARY:
PRIMARY RESPONSIBILITIES:
MINIMUM QUALIFICATIONS:
KNOWLEDGE, SKILLS, AND ABILITIES:
COMPENSATION AND CLASSIFICATION:
Click here for a direct link to the company posting and to apply.
Position Title: Senior Regulatory Affairs Specialist, Inflammatix
Inflammatix is seeking a Senior Regulatory Affairs Specialist to collaborate on multiple submissions in a nascent Regulatory Affairs team. This position reports to the Head of Regulatory Affairs. The Senior Regulatory Affairs Specialist contributes to establishing global regulatory strategy in collaboration with cross functional stakeholders and is responsible for timely execution of the strategy for new and existing products to ensure compliance with global regulatory requirements.
POSITION SUMMARY:
- Support the development and implementation of strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, and marketing applications
- Ensure timely preparation of organized and scientifically valid applications; provide expertise in translating regulatory requirements into practical, workable solutions
- Provide input into post-market activities, including complaint handling, adverse event reporting and field corrects/recalls
PRIMARY RESPONSIBILITIES:
- Support meeting regulatory responsibilities associated with the development, support, and manufacturing of the Company’s medical device products
- Support the development and implementation of Regulatory strategies and plans to support the timely introduction of new products and the preparation of submissions to achieve timely and cost-effective clearance/approval
- Provide information for maintaining registrations and listings
- Monitor and assess Regulatory developments (e.g., Federal Register publication/notices, FDA guidelines, etc.) and change management related to the Company’s products
- Review product labeling to ensure conformance with Regulatory requirements and/or approved product claims
- Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle
- Support internal and external audits; collaborate with Quality Assurance to coordinate strategy and provide responses to audit requests and inquiries
- Write and implement appropriate procedures and processes as needed
MINIMUM QUALIFICATIONS:
- Bachelor's degree in a physical or life science related fields
- A minimum of 5 years regulatory affairs experience in the medical device industry
- Experience with ISO 13485:2016 and 21 CFR Part 820
- Experience with IVDD and IVDR requirements
- Experience preparing technical documents and submission dossiers
- Experience with IVD (strongly preferred)
- Broad knowledge of and experience with US, EU, and Rest-of-World medical device registration processes (preferred)
- Regulatory Affairs certificate from RAPS or other organization (preferred)
- Experience with 510(k) submission (preferred)
KNOWLEDGE, SKILLS, AND ABILITIES:
- High ethical standards and integrity
- Ability to work well independently and in a team environment, interact productively, and effectively with peers, management, and third parties
- Proficiency with Microsoft Office including Word, Excel, and PowerPoint
- Excellent written and verbal communication skills; attention to details
- Ability to maintain a high level of confidentiality
- Use resources effectively and reasonably
- Perform other duties and assignments as required
COMPENSATION AND CLASSIFICATION:
- Classification: Full-time position
- Compensation: Competitive and commensurate with experience; equity package
- Benefits: Medical, dental, and vision; 401(k) and more
Click here for a direct link to the company posting and to apply.
Posted Date: 2/2/2022
Position Title: Senior Systems Engineer, Clinical Products, STEMCELL Technologies
Link to apply: https://stemcell.wd3.myworkdayjobs.com/External_Careers/job/Canada---BC-Burnaby/Senior-Systems-Engineer--Clinical-Products_R0003836
Job Description Summary:
The Senior Systems Engineer, Clinical Products has overall technical responsibility for the design, certification and commercialization of instruments developed by STEMCELL Technologies targeted at the clinical market. The Senior Systems engineer will lead a team of engineers and work closely with customers, suppliers and scientific teams to design and deliver solutions based on both existing and new technologies. This is a technical leadership position requiring a broad range of technical, scientific and interpersonal skills with an opportunity to grow and develop the role within STEMCELL.
You will be part of a dynamic product development team responsible for the design, expansion and continuous innovation of our lab instrumentation product offerings as well as their associated consumables. As Canada’s largest biotechnology company, STEMCELL Technologies Inc. provides leading edge robotic, software and reagent solutions that drive our customers' research and therapeutic activities at the forefront of science. The role provides an opportunity to contribute to product development, innovation and solution provision for our customers, as well as to maintain our leadership presence in the life sciences industry.
Duties and Responsibilities:
Qualifications:
This role requires being fully vaccinated against COVID-19 as per STEMCELL’s vaccination policy, the current recommendations by local health authorities and as required by public health orders in place from time to time, including any COVID-19 boosters as recommended by local health authorities and as required by public health orders in place from time to time.
Position Title: Senior Systems Engineer, Clinical Products, STEMCELL Technologies
Link to apply: https://stemcell.wd3.myworkdayjobs.com/External_Careers/job/Canada---BC-Burnaby/Senior-Systems-Engineer--Clinical-Products_R0003836
Job Description Summary:
The Senior Systems Engineer, Clinical Products has overall technical responsibility for the design, certification and commercialization of instruments developed by STEMCELL Technologies targeted at the clinical market. The Senior Systems engineer will lead a team of engineers and work closely with customers, suppliers and scientific teams to design and deliver solutions based on both existing and new technologies. This is a technical leadership position requiring a broad range of technical, scientific and interpersonal skills with an opportunity to grow and develop the role within STEMCELL.
You will be part of a dynamic product development team responsible for the design, expansion and continuous innovation of our lab instrumentation product offerings as well as their associated consumables. As Canada’s largest biotechnology company, STEMCELL Technologies Inc. provides leading edge robotic, software and reagent solutions that drive our customers' research and therapeutic activities at the forefront of science. The role provides an opportunity to contribute to product development, innovation and solution provision for our customers, as well as to maintain our leadership presence in the life sciences industry.
Duties and Responsibilities:
- Drives multi-disciplinary teams consisting of Mechanical, Electrical and Software engineers, Product Managers and Quality specialists, to define, develop and launch new clinical and laboratory automation systems from requirements gathering through architectural design and prototyping to detailed design, test and manufacturing.
- Leads technical efforts to generate, review and approve all deliverables required for a regulatory approval of a clinical instrumentation product, continually working closely with in-house Quality Assurance specialists on this.
- Developing and documenting system level requirements working with in-house teams, contract manufacturers, customers and suppliers including all sub-systems and interfaces.
- Creates all required Design History File documentation for clinical products including but not limited to: design and development plan; system verification and validation plans; test protocols; and risk analysis.
- Ensures the team is following the design and development plan and STEMCELL’s internal quality management system standard operating procedures.
- Plans system performance testing (reliability and biological) as part of a cross-functional team of engineers and scientists in order to mitigate risks early in product development and validate final system performance.
- Analyzes and solves complex problems, drives design reviews that affect the product life cycle such as manufacturing, service, regulations, troubleshooting, upgrades and backwards compatibility, competing technology and obsolescence.
- Contributes to annual departmental objectives and projects as part of strategic planning; and recommends improvements to policies and procedures of the business unit.
- Contributes to defining the work program and technical activities schedule for projects. Actively participates in brainstorming and review sessions.
- Provides feedback and mentorship to staff.
Qualifications:
- A bachelor’s degree in Systems, Mechanical, Electrical or Biomedical Engineering, or in a similar appropriate field, with 10+ years of relevant experience or a master’s degree in Engineering with 8+ years of relevant experience.
- Proven experience with system engineering principles, including requirements analysis and allocation, architecture definition, verification and validation and with technical documentation and its use in product development from requirements gathering to validation, manufacture, support and end of life.
- Experience with DFMEA and medical device and regulatory standards including 21 CFR 820, GMP, GLP, IEC 61010, IEC 62304, ISO 13485 including traceability of requirements and test results for diagnostic and clinical applications.
- Demonstrated skills and experience in novel and standard design approaches, building and testing of electromechanical systems and solving complex cross-disciplinary problems.
- Knowledge of automation system applications and specific knowledge of one or more of: Liquid handling systems, Robotic and linear / rotary motion control systems, Linear and rotary actuators and end effectors, Sensors and measurement instruments including data acquisition, Embedded controllers, PC and laptop interfaces for analog and digital IO
- Extensive experience with diverse technologies, carrying out design reviews and technology assessments and familiar with standard industry best practices, 3D CAD, PLM applications and version control of software and/or hardware design.
- Experience in leading projects and managing third party contractors in the design and supply of automation systems is a distinct asset.
- Practical experience in designing for low to mid-level production volumes.
- Demonstrated project management and planning experience in a multi-project, time-driven environment, including budgeting, resource and change management.
- Excellent communication skills (verbal, written, presentation) and with experience of managing external suppliers.
- Team oriented yet self-motivated.
- Highly organized with strong attention to detail and accuracy.
This role requires being fully vaccinated against COVID-19 as per STEMCELL’s vaccination policy, the current recommendations by local health authorities and as required by public health orders in place from time to time, including any COVID-19 boosters as recommended by local health authorities and as required by public health orders in place from time to time.
Posted Date: 1/21/2022
Position Title: Regulatory and Clinical Development Specialist, Molecular Testing Labs
Reports To: Head of Laboratory Operations and R&D
Position status: Exempt; Full Time
Primary Function:
The Regulatory and Clinical Development Specialist ensures that our products and
procedures adhere to superior regulatory compliance standards. In addition, the
development specialist assists in development of new assays that may eventually be
submitted for FDA review.
Essential Duties and Responsibilities:
Plan, review, write and prepare documents for FDA pre-submission meetings,
510(k), and/or PMA applications for product approvals/clearances required by the
US FDA, ISO accreditation, and possibly international regulatory agencies. Ensures
regulatory submissions are prepared and processed in a proactive, expeditors and
timely manner.
Prepare and file 510(k), PMA, PMA supplement, notification etc. based on the
technical information provided by the development project team.
Writes, edits and prepares study protocols planned for FDA submissions.
Works with the R&D and technical team in researching and developing new assays,
including literature searches, in-lab technical development, and report generation.
Follow through to completion by tracking its review progress at FDA and
coordinating any response to FDA requests for further information.
Represents the business in interactions with regulatory authorities.
Accountable for establishing, maintaining, adjusting and communicating regulatory
submission deadlines to ensure that product-launch related functional area activities
can be planned accordingly.
Support complex product development regarding clinical analytical study designs
during the product development (pre-submission) phase, and appropriateness of
product claims, and wording/interpretation/presentation of performance during
verification/validation (pre-clearance/approval) phase.
Identifies potential risks and risk mitigation strategies to supervisors.
Manages and executes the regulatory review of labels, labeling, advertising and
promotional materials.
Participating in development discussions and assisting other associates with
developmental tasks and products
Maintains proactive and positive working relationship with internal and external
personals to ensure the business is positioned to meet strategic corporate goals.
Independently manages and monitors multiple complex, novel and/or diverse
products simultaneously.
Support complex product development regarding clinical analytical study designs
during the product development (pre-submission) phase, and appropriateness of
product claims, and wording/interpretation/presentation of performance during
verification/validation (pre-clearance/approval) phase.
Identifies potential risks and risk mitigation strategies to supervisors.
Manages and executes the regulatory review of labels, labeling, advertising and
promotional materials.
Participating in development discussions and assisting other associates with
developmental tasks and products
Maintains proactive and positive working relationship with internal and external
personals to ensure the business is positioned to meet strategic corporate goals.
Independently manages and monitors multiple complex, novel and/or diverse
products simultaneously.
All other reasonable duties as assigned.
Skills, Knowledge, Abilities
Mental Abilities and Skills Requirements
Must have excellent written and oral communication skills
Above average computer skills (MS Word, Excel, Access, PowerPoint, etc.) are
required.
Knowledge of Federal Regulation Coding pertaining to medical devices, and
premarket notifications and premarket approvals.
Education and Certification
Education/Experience Requirements –
Bachelor’s degree in immunology, molecular biology, biology, biochemistry, or
similar is required.
Advanced degree in immunology, molecular biology, biology, biochemistry, or similar
is preferred.
At least 5 years of experience directly related to regulatory experience in the medical
device and/or in vitro diagnostic device area(s) is preferred.
Should have experience, and be familiar, with FDA regulations, guideline and
requirements related to GLP or experience with similar submissions such as grant
proposals; highly developed organizational skills are a must
Physical Requirements:
Must be able to sit or stand for up to 8 hours per day.
Occasionally required to lift up to 20 lbs
Regularly required to sit, stand, bend, reach and move about facilities.
Work Environment:
VANCOUVER, WASHINGTON OFFICE - Some work will be performed in an office.
LAB POSITIONS - Most work will be performed in the lab. However, this position will
require some traveling and working between locations. Workweeks usually consist of 40
hours.
Office Environment -
Several common areas and meeting rooms for collaboration
Large windows which let in natural light during working hours
Fully equipped break room and bathrooms.
Lab Environment -
Noise levels vary based on flow of business
Most floors are tile or concrete - individuals may stand for extended periods of time
on these surfaces
Tools and Technology:
Desktop computer and laptop
Scanners and printers
Hazards:
Work is performed in a office environment, full manual dexterity and visual acuity
required. However, access to the laboratory may be necessary and therefore
employee may be exposed to potential physical harm from hazardous chemicals,
infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical
hazards, dangerous tools and equipment.
Hep B Vaccination provided at no cost to employee
To apply:
Interested applicants should contact Adrienne Hagen, HR & Compliance Specialist at ahagen@moleculartestinglabs.com
Position Title: Regulatory and Clinical Development Specialist, Molecular Testing Labs
Reports To: Head of Laboratory Operations and R&D
Position status: Exempt; Full Time
Primary Function:
The Regulatory and Clinical Development Specialist ensures that our products and
procedures adhere to superior regulatory compliance standards. In addition, the
development specialist assists in development of new assays that may eventually be
submitted for FDA review.
Essential Duties and Responsibilities:
Plan, review, write and prepare documents for FDA pre-submission meetings,
510(k), and/or PMA applications for product approvals/clearances required by the
US FDA, ISO accreditation, and possibly international regulatory agencies. Ensures
regulatory submissions are prepared and processed in a proactive, expeditors and
timely manner.
Prepare and file 510(k), PMA, PMA supplement, notification etc. based on the
technical information provided by the development project team.
Writes, edits and prepares study protocols planned for FDA submissions.
Works with the R&D and technical team in researching and developing new assays,
including literature searches, in-lab technical development, and report generation.
Follow through to completion by tracking its review progress at FDA and
coordinating any response to FDA requests for further information.
Represents the business in interactions with regulatory authorities.
Accountable for establishing, maintaining, adjusting and communicating regulatory
submission deadlines to ensure that product-launch related functional area activities
can be planned accordingly.
Support complex product development regarding clinical analytical study designs
during the product development (pre-submission) phase, and appropriateness of
product claims, and wording/interpretation/presentation of performance during
verification/validation (pre-clearance/approval) phase.
Identifies potential risks and risk mitigation strategies to supervisors.
Manages and executes the regulatory review of labels, labeling, advertising and
promotional materials.
Participating in development discussions and assisting other associates with
developmental tasks and products
Maintains proactive and positive working relationship with internal and external
personals to ensure the business is positioned to meet strategic corporate goals.
Independently manages and monitors multiple complex, novel and/or diverse
products simultaneously.
Support complex product development regarding clinical analytical study designs
during the product development (pre-submission) phase, and appropriateness of
product claims, and wording/interpretation/presentation of performance during
verification/validation (pre-clearance/approval) phase.
Identifies potential risks and risk mitigation strategies to supervisors.
Manages and executes the regulatory review of labels, labeling, advertising and
promotional materials.
Participating in development discussions and assisting other associates with
developmental tasks and products
Maintains proactive and positive working relationship with internal and external
personals to ensure the business is positioned to meet strategic corporate goals.
Independently manages and monitors multiple complex, novel and/or diverse
products simultaneously.
All other reasonable duties as assigned.
Skills, Knowledge, Abilities
Mental Abilities and Skills Requirements
Must have excellent written and oral communication skills
Above average computer skills (MS Word, Excel, Access, PowerPoint, etc.) are
required.
Knowledge of Federal Regulation Coding pertaining to medical devices, and
premarket notifications and premarket approvals.
Education and Certification
Education/Experience Requirements –
Bachelor’s degree in immunology, molecular biology, biology, biochemistry, or
similar is required.
Advanced degree in immunology, molecular biology, biology, biochemistry, or similar
is preferred.
At least 5 years of experience directly related to regulatory experience in the medical
device and/or in vitro diagnostic device area(s) is preferred.
Should have experience, and be familiar, with FDA regulations, guideline and
requirements related to GLP or experience with similar submissions such as grant
proposals; highly developed organizational skills are a must
Physical Requirements:
Must be able to sit or stand for up to 8 hours per day.
Occasionally required to lift up to 20 lbs
Regularly required to sit, stand, bend, reach and move about facilities.
Work Environment:
VANCOUVER, WASHINGTON OFFICE - Some work will be performed in an office.
LAB POSITIONS - Most work will be performed in the lab. However, this position will
require some traveling and working between locations. Workweeks usually consist of 40
hours.
Office Environment -
Several common areas and meeting rooms for collaboration
Large windows which let in natural light during working hours
Fully equipped break room and bathrooms.
Lab Environment -
Noise levels vary based on flow of business
Most floors are tile or concrete - individuals may stand for extended periods of time
on these surfaces
Tools and Technology:
Desktop computer and laptop
Scanners and printers
Hazards:
Work is performed in a office environment, full manual dexterity and visual acuity
required. However, access to the laboratory may be necessary and therefore
employee may be exposed to potential physical harm from hazardous chemicals,
infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical
hazards, dangerous tools and equipment.
Hep B Vaccination provided at no cost to employee
To apply:
Interested applicants should contact Adrienne Hagen, HR & Compliance Specialist at ahagen@moleculartestinglabs.com