Manager, Regulatory Affairs
Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,500 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
Patients First | Innovation | Winning Culture | Heart Recovery
The Regulatory Affairs Manager will prepare global regulatory documents and submissions, according to Abiomed standards, for all Abiomed product lines. This key team member will play a crucial role in ensuring that our heart recovery therapy is available to patients in need, and they will play a significant role in the growth of the company. If you are detail-oriented Regulatory Affairs professional who is passionate about making a difference in patients’ lives every day, we are interested in hearing from you.
- Regulatory lead/representative on project core teams (new product development, manufacturing, obsolescence, new suppliers, etc.) providing regulatory input on all matters
- Performs regulatory impact assessments for manufacturing and product changes for notification to regulatory agencies.
- Prepares regulatory plans and prepares needed regulatory submissions and associated documents for FDA, Health Canada, Notified Bodies, PMDA and ROW countries and secures approvals
- Conducts training programs to educate employees on regulatory processes and requirements
- Communicates with regulatory agencies regarding clarification of or follow-up of submissions under review
- Reviews technical reports for incorporation into regulatory submissions
- Maintains company registration and device listings for global regulatory agencies
- Regulatory liaison/representative in internal or external audits
- Maintains current knowledge base of existing and emerging regulations, standards and guidance documents
- Identifies relevant guidance documents, international regulations and standards and provides interpretive assistance for new filings
- Prepares and maintains technical files as necessary to obtain and sustain product approvals
- Compiles and maintains regulatory documentation databases and tracking systems
- 5+ years of medical device Regulatory Affairs experience with a track record of successful submissions
- Experience preparing & defending regulatory submissions to the FDA (PMA, 510(k), Qsubs, IDE’s, PMA Annual Reports, etc. are particularly preferred)
- Fluency in Japanese strongly preferred
- Willingness & ability to travel to Danvers, MA headquarters approximately once a month (10-15% of the time)
- BS degree (preferably in Regulatory Sciences / Practices, etc.), or equivalent experience with RA coursework/seminars
- Indepenence and self-direction coupled with a strong desire to work collaboratively as part of a high-performing team
- Outstanding written and verbal communication skills
- Keen ability to prioritize work and execute in an environment of competing priorities
- Strong organizational skills
- Strong technical / computer skills
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Job posted: 2021-03-13