Sr. Regulatory Affairs Specialist Trauma
Synthes - West Chester, PA

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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:
  • 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
Professional Experience & Educational Requirements :
  • 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 - save job - block
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