Provide regulatory support for assigned projects, both pre- and post-market.
Interface with Product Development groups to discuss US, Canada, and EU regulatory requirements and pathways to market.
Develop regulatory strategies for new/modified products.
Duties & Other Responsibilities:
Professional Experience & Educational Requirements :
- Prepare and submit US FDA and Health Canada regulatory documentation for assigned products, including original submissions and any subsequent correspondence.
- Engage regulators, when necessary, in oral communications to discuss pending or new submissions, regulatory requirements, etc.
- Develop and propose regulatory pre-market strategies in cooperation with other departments, and other Synthes locations as dictated
- Work cooperatively with Product Development groups to achieve compliance with regulatory requirements.
- Review Document Change Orders (DCOs) for compliance with regulatory requirements
- Review/approve labeling: device labels, brochures, technique guides, bulletins, updates, etc.
- Review promotional materials for compliance with regulatory clearance/approval. Review presentation materials for Synthes-sponsored events for compliance, particularly in respect to claims, intended use and indications.
- Prepare export certificates and medical device listings
- Obtain and maintain Certificates to Foreign Governments and Certificates for Export
- Regulatory records retention (update electronic regulatory archives with all cleared and/or approved regulatory submissions).
- Maintain regulatory database (JDE) - ongoing update of database with regulatory information
- Keep current in regard to US and Canadian regulations, guidance documents, Federal Register notices, and competitor news.
- Provide assistance and guidance to junior staff members.
- Participate in cross-functional projects teams, as assigned.
- Participate in profession organization(s) e.g. RAPS, AAMI, ASTM, etc.
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
- Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
- Other duties as assigned
- Must be flexible, cooperative, and team-oriented
- Must be able to build strong relationships and work well with other departments.
- Excellent written and oral communication skills
- Ability to handle multiple tasks and be detail oriented
- Advanced computer skills, specifically MS Word and Adobe
- Four + years of prior regulatory experience in medical devices and/or pharmaceuticals
- Demonstrated knowledge of US Food, Drug and Cosmetic Act as amended
- Knowledge of U.S. FDA medical device regulations and guidance documents
- Working knowledge of electronic submissions
- BA/BS Degree from an accredited four year college or university
- Scientific or Technical Degree preferred
- Regulatory Affairs Certification (RAC) preferred, not required
Synthes - 17 months ago