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.