Job Postings
AMDM posts open positions within the IVD Industry.
The charges for a 60-day posting for AMDM Members are $150 (Join AMDM), and $300 for Non-Members. A general notice of a new posting to the AMDM database is also included.
To post your open position, please send your job description with contact information to amdm_secretary@att.net. Jobs will be published on this page within 48 hours and a notice sent to the AMDM database alerting them to the new posting. An invoice will be emailed.
The charges for a 60-day posting for AMDM Members are $150 (Join AMDM), and $300 for Non-Members. A general notice of a new posting to the AMDM database is also included.
To post your open position, please send your job description with contact information to amdm_secretary@att.net. Jobs will be published on this page within 48 hours and a notice sent to the AMDM database alerting them to the new posting. An invoice will be emailed.
Director, Regulatory Affairs, Hycor Biomedical -posted 12.7.16
Location: Garden Grove, CA (Will relocate from anywhere in the USA)
THE ESSENTIAL FUNCTIONS OF THIS POSITION ARE AS FOLLOWS:
• Develop and implement regulatory strategies per the company long range plans
• Ability to write, review and/or submit regulatory documentation for US FDA 510(k) submissions, EU
technical files and other country submissions as required
• Complete annual country registrations (US, Canada, others as required)
• Interact with applicable Notified Bodies
• Manage EU Authorized Representative
• Responsibility for the results of the regulatory affairs activities, associated documentation and
compliance.
• Manage personnel in the Regulatory department and assures their safe performance.
• Develop and maintain budget for the Regulatory department.
• Ensure the Company has systems in place that maintain regulatory compliance of its products and
services.
• Ensure the Company complies with local, state, federal and international regulations and standards for
the products and services it produces.
• Ensure that processes needed for regulatory affairs are established, implemented and maintained.
• Report to top management on the performance of the regulatory system and any need for improvement.
• Ensure the promotion of awareness of regulatory, compliance and customer requirements throughout the
organization.
• Serve as liaison with external parties on matters relating to the regulatory affairs system.
• Coordinate with top management to ensure that appropriate communication processes are established
within the organization and that communication takes place regarding the effectiveness of the regulatory
system.
• Maintain punctuality and regular attendance.
• Interact with all co-workers and management in a positive, supportive and cooperative way.
QUALIFICATIONS REQUIRED:
Education: Bachelor of Science Degree in life sciences or related field, MBA a plus
Licenses/Certifications: Regulatory Affairs Professionals Society Certifications (US, EU)
Skills/Abilities: General upper level management skills; top oral/written communications; problem-solving; technical aptitude. Knowledge of FDA regulations, international quality standards and regulations, and local and federal regulations relating to the medical diagnostics industry.
Experience: 12+ years managing medical device regulatory affairs (in-vitro diagnostic devices preferred). Experience with registrations in Japan and China a plus.
To apply, please contact Jim Olsen at 312-224-8479 or JOlsen@hycorbiomedical.com
Location: Garden Grove, CA (Will relocate from anywhere in the USA)
THE ESSENTIAL FUNCTIONS OF THIS POSITION ARE AS FOLLOWS:
• Develop and implement regulatory strategies per the company long range plans
• Ability to write, review and/or submit regulatory documentation for US FDA 510(k) submissions, EU
technical files and other country submissions as required
• Complete annual country registrations (US, Canada, others as required)
• Interact with applicable Notified Bodies
• Manage EU Authorized Representative
• Responsibility for the results of the regulatory affairs activities, associated documentation and
compliance.
• Manage personnel in the Regulatory department and assures their safe performance.
• Develop and maintain budget for the Regulatory department.
• Ensure the Company has systems in place that maintain regulatory compliance of its products and
services.
• Ensure the Company complies with local, state, federal and international regulations and standards for
the products and services it produces.
• Ensure that processes needed for regulatory affairs are established, implemented and maintained.
• Report to top management on the performance of the regulatory system and any need for improvement.
• Ensure the promotion of awareness of regulatory, compliance and customer requirements throughout the
organization.
• Serve as liaison with external parties on matters relating to the regulatory affairs system.
• Coordinate with top management to ensure that appropriate communication processes are established
within the organization and that communication takes place regarding the effectiveness of the regulatory
system.
• Maintain punctuality and regular attendance.
• Interact with all co-workers and management in a positive, supportive and cooperative way.
QUALIFICATIONS REQUIRED:
Education: Bachelor of Science Degree in life sciences or related field, MBA a plus
Licenses/Certifications: Regulatory Affairs Professionals Society Certifications (US, EU)
Skills/Abilities: General upper level management skills; top oral/written communications; problem-solving; technical aptitude. Knowledge of FDA regulations, international quality standards and regulations, and local and federal regulations relating to the medical diagnostics industry.
Experience: 12+ years managing medical device regulatory affairs (in-vitro diagnostic devices preferred). Experience with registrations in Japan and China a plus.
To apply, please contact Jim Olsen at 312-224-8479 or JOlsen@hycorbiomedical.com
