Candidate will be responsible for developing and implementing documentation policies and practices that comply with US and International regulatory agencies with respect to cardiovascular device products.  Candidate will prepare regulatory submissions for new products/product changes to ensure timely approval for market release and will follow up with regulatory agencies on these submissions.  Candidate will serve as regulatory affairs representative to product development teams to provide guidance on regulatory issues and filing activities.  Candidate will be responsible for producing document packages for regulatory submission (including 510(K), CE Technical Documentations, Canada Device Applications, etc.) and will review documents that may impact regulatory submissions/approvals.

The Regulatory Affairs Manager will report to the VP of Regulatory Affairs and have the following primary responsibilities:

• Responsible for preparation of regulatory submissions, including FDA 510(K), CE Technical Documentations, Canadian Device Applications, etc.
• Review significant product submission issues and may negotiate submission issues with the regulatory agencies.
• Provide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval.
• Provide on-going support to product development teams for regulatory strategy and questions.
• Review regulations and guidance to keep apprised of new regulatory developments.
• Mentor junior RA Specialists.
• Other responsibilities assigned by the management.

Pay range $110,000-$150,000 per year plus bonus. The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. The actual base salary pay will be based on a number of factors such as education, qualifications, certifications, experience, and other job-related factors permitted by law.

• Bachelor's degree from four-year college or university 
• At least 8 years related experience in a regulatory role (medical device)
• Authored 510k and/or CE Technical Documentation
• Ability to read, analyze, and interpret general, professional journals, technical procedures, and regulations.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the regulators.
• Fluent in English
• Ability/experience to understand scientific/technical aspects of the medical devices, preferentially for vascular devices.
• Familiar with biocompatibility, sterilization, packaging, shelf life and associated ISO standards.
• Ability to work full-time onsite at company’s facility.
• RAC certified is a plus.