The Sr. Regulatory Affairs Specialist will prepare global regulatory documents and submissions, according to Abiomed standards, for a novel ECMO therapy with recent 510k approval. This key team member will play a crucial role in ensuring that novel therapy is available to patients in need, and they will play a significant role in the growth of this product. 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 Regulatory Affairs experience in medical device industry with a track record of successful submissions
Experience preparing & defending regulatory submissions to the FDA, specifically 510k submissions (PMA, Qsubs, IDE's, PMA Annual Reports, etc. preferred)
BS degree, or equivalent experience with additional courses or seminars in Regulatory Submissions
Willingness & ability to travel to Danvers, MA headquarters approximately once a month (10-15% of the time)
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
Internal Number: 7654
About Abiomed, Inc.
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.