Post by Jobing - Leading biotechnology company has a direct hire opening for a Regulatory Affairs Specialist to join their team. This position is responsible for coordinating the accumulation of technical information and preparing submissions for therapeutic, medical, or diagnostic device licenses to various governmental regulatory agencies. In addition, this person will act as Company Health & Safety Officer in protecting employees, workplace and ensuring compliance with government requirements. •Coordinates submission and review of documents for inclusion in Design History files.
- Drafts, edits and compiles technical files and design dossier in support of EU regulatory filings. •Process Interface agreements with OEM customers to ensure compliance with IVDD and MDD. •Assists with the preparation of annual surveillance reports on approved products. •Assists in the preparation of incident reports and recalls/notifications as needed.
- Prepare regulatory submissions (FDA 510(k)s, Technical files for CE Marking & Pre–market Review Documents for Canada Device License Applications). •Registration/Application of Class II & III Medical Devices Licenses in Health Canada. •Research FDA, CMDR, MDD & IVDD guidance documents for regulatory requirements. •Assist OEM customer in obtaining the CE mark on their products.
- Inspections: inspect the workplace for potential hazards, identify potential hazards, assess the risks and report potential hazards. •Conduct fire drills, to ensure equipment is properly functioning and staffs are aware of what to do in an emergency. •Conduct investigations: respond to and investigate accidents and emergencies. •Ensure the organization is compliant with legislative and regulatory requirements, conduct trainings with staff to make sure they are aware of regulations and procedures and provide guidance.
- Act as representative in interaction with government agency for safety inspection. •Other duties as assigned. Requirements: •Bachelor's Degree in related discipline or equivalency; •Minimum 5 years industry experience; •Minimum 3 years exper in preparation and submission of 510k and CE technical files; •Experience in managing submission compilation and cross functional review; •Knowledgeable with QSRs & ISO 13485, IVDD, MDD, CMDR, GMP, and 21 CFR; •Strong computer skills using MS Office applications; •IVD experience and clinical study onto IVD application is a plus Qualified candidates please submit your resume as a Word document (preferred) for immediate consideration.