12 months ago
Do you want to increase organ utilization, improve patient outcomes and reduce transplant costs throughout the health care system? If you want to work for the world’s leader in portable ex vivo perfusion and assessment of donor organs for transplantation, then apply now!
Title: Director of Regulatory Affairs
Type: Regulatory Affairs
Location: Andover, Massachusetts
Essential job duties
- The Director of Regulatory Affairs will be working with Class III product in the US and internationally.
- Manage and mentor junior RA staff members to become self-sufficient in efficiently completing their RA tasks
- Update and maintain technical files and other regulatory applications internationally
- Create methods to achieve FDA and international regulatory approvals of Class II/III applications
- Prepare and review FDA and international applications and other regulatory documents including EU Technical Files, PMAs and PMA Supplements, IDEs and IDE Supplements, Annual Reports for PMAs, IDEs and MDRs
- Participate in FDA and ISO audits for QSR and BIMO compliance
- Enhance and maintain positive relationships with the FDA and other international agencies
- At least 10 years of regulatory affairs experience in the medical device industry, working with class III devices
- Strong experience and proven track record in successful regulatory submissions in the US and globally
- Strong project management and leadership skills
- Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results
- Bachelor’s degree in engineering or Life or Biological Sciences required, Masters or PhD preferred
If you are interested in this position and your experience meets the below requirements, please apply via the button below. If you do not receive a response on your application in 3-5 working days, please assume your application has been unsuccessful on this occasion.
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Catalyst Life Sciences
Catalyst Life Sciences is a recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets;
- Pharmacovigilance/Drug Safety
- Regulatory Affairs
- Quality Assurance
- Quality Control
- Medical Information
- Medical Writers
- Medical Affairs
- Clinical Trials
- Clinical Research
- Project Management