To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02653

About our client Our client is one of the world's leading medical device providers. They are a highly profitable, publicly traded company whose products are currently being sold in over 120 countries worldwide. This is a great opportunity for someone to join a company that offers a great corporate culture and is focused on the long-term development of its employees. Position Location Senior Regulatory Affairs Specialist Michigan Salary Highly competitive package, commensurate with experience Responsibilities 1) Implement international and domestic regulatory strategies 2) Prepare 510(k) PMAs and IDEs submission applications 3) Research current domestic and international regulatory requirements 4) Prepare and design dossiers for review by notified body 5) Submit product registrations and applications to foreign governments (as required i.e. TGA, DOH) 6) Review and approve product changes in accordance with regulatory guidelines 7) Participate and contribute to project teams 8) Review and approve advertising and promotional materials for regulatory implications Requirements 1) BS in a related field (advanced degree preferred) 2) Minimum 5 years of experience in regulatory/clinical affairs 3) Experience and expertise in PMA, 510(k) and IDE submissions 4) Experience in Class III implant-able device submissions 5) Experience in powered implant-able devices preferred 6) Experience in international regulatory submissions a plus 7) Experience in working with contract service providers, including technical transfer, site qualification and supervision of activities 8) Experience in working as the Lead of Design Team in the commercialization of Class III products for cardiac, spinal or neurological applications 9) RAPS certification a plus 10) Technical writing and fundamental problem-solving skills 11) Innovative, people-oriented with good project-management skills 12) Ability to work independently