Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Regulatory Affairs Specialist to be located in Cincinnati, OH.
Ethicon develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastro-intestinal health, gynecology and surgical oncology.
The Senior Regulatory Affairs Specialist will conduct a refreshingly wide range of regulatory activities necessary for the timely preparation, writing and filing of 510(k) Pre-market Notifications, European submissions, and support international product registrations. The role will manage the global regulatory aspects of new product development and supply chain distribution for specified products with minimal direction from management.
- Prepare and submit documents necessary to gain US and international regulatory approvals / clearance to place new or modified products into worldwide commercial distribution
- Stay continually aware of new product development activities through ongoing communication with Marketing and Research & Development departments, in addition to supporting portfolio management
- Provide expertise, make recommendations and give regulatory direction as an integral member of new product development team
- Provide regulatory support to medical affairs, supply chain teams, analyze technical reports, and review advertising and promotional materials
- Communicate with department members, government agencies and a host of individuals outside the company in a professional, decisive, and articulate manner
- Make recommendations and provide guidance to marketing, product development, technical writers, and package engineering regarding label content
- A minimum of a Bachelor's degree in life science, engineering, medical/scientific writing, public health administration or a related area is required.
- An advanced degree in a technical, medical, or business area is an asset.
- RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society is preferred.
- A minimum of 4 years of successful experience in a regulated healthcare environment (device, pharmaceutical, biologics company, etc.) is required.
- Experience with US regulatory submissions, such as 510(k), NDA, or PMAs, is required.
- It is preferred that this individual has experience with or exposure to international regulatory requirements.
- Device submissions experience is preferred.
- Experience with IDEs (Investigational Device Exemptions), PMA Supplements and/or Annual reports, Clinical Trial Dossiers (CTD), Design Dossiers/Renewals, Technical Files, and/or Clinical Trials is an asset.
- Broad based experience across various disciplines is useful.
- This position will be located in Cincinnati, Ohio and may require up to 10% travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Ethicon Endo Surgery Inc (6041)