Medical Device Director of Regulatory Affairs

 

An experienced Director of Regulatory Affairs is sought by a San Clemente, California based venture start up Medical Device company which is about to embark on a large complex international clinical study.

The successful candidate MUST have a demonstrated track record of providing direction, project management, structure, and strategy for the company’s regulatory goals. Additionally the candidate must have direct experience writing, submitting, and defending regulatory submissions resulting in successful regulatory approvals for complex Class III medical devices in the United States, as well as pilot and CE marking trials in Europe. This includes the entire progression of the company’s products from concept to clinical trial, and through the regulatory process to final market approval. The director is also an integral member of the new product development team. This position will work closely with counterparts within the Marketing & Sales, R&D and Process Engineering and Accounting groups to assure that the products derived are done so in accordance with the Quality System and the Company milestones. The company offers competitive compensation packages including an incentive compensation plan, pre-IPO stock options, health, and life insurance, 401(k) and employee stock purchase plans.