Website Johnson & Johnson
The successful candidate will develop and implement strategies and processes to achieve timely commercialization of innovative medical products in compliance with applicable regulations and standards.
- Produce and manage the generation of documentation to be submitted to worldwide governmental regulatory agencies to secure approvals for marketing products manufactured and/or distributed by BWI and/or J&J affiliates.
- Ensure timely approvals, communicate and conduct negotiations with the FDA and other regulatory bodies as needed to identify pre-submission requirements and strategy and to resolve post-submission queries and issues.
- Support development teams working towards modifying existing devices or creating new products; ensure compliance with design controls, risk management, and domestic and international regulations.
- Maintain proficiency on regulatory requirements; develop and maintain rapport with FDA/Notified Body reviewers.
- Be responsible for ensuring personal and Company compliance with all Federal, State local, and Company regulations, policies, and procedures.
- Establish and support policies and standards for new products while ensuring compliance with global regulations and regulating agencies.
- Develop EU MDR compliant Technical Documentation for class II and III medical devices to support CE Mark approval.
- Provide continuing regulatory education and disseminate regulatory information to the product development, marketing, and clinical groups.
- Instill and drive a vibrant regulatory culture, working among functional groups as a teammate and collaborator to develop successful regulatory strategies.
- Develop IDE, 510(k) and PMA submissions for class II and III medical devices for commercialization in the USA.
- Interpret the intent of regulations and policies and provide such information to project teams and management.
- Ensure that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
- Experience in the neurovascular field is preferred.
- Ability to make difficult decisions is required.
- Knowledge of other international medical device requirements (e.g. China, Japan) is preferred.
- Ability to manage and prioritize effectively in a multifaceted environment is required.
- Regulatory submission experience (i.e. 510(k), PMA, etc.) is required.
- Experience in evaluating and managing regulatory implications associated with changes in medical device design and manufacturing is required.
- Demonstrated expertise in a broad range of Regulatory Affairs subjects.
- Working knowledge of FDA and EU Medical Device Directive and Medical Device Regulations is required.
- Domestic and international travel up to 10% may be required.
- Strong negotiation skills as they relate to regulatory bodies. History of building relationships and successful interaction with FDA and/or Notified Bodies is required.
- Strong interpersonal, organizational and problem-solving skills are required.
- Project Management experience is preferred.
- RA lead on a cross-functional teams (negotiation, leading RA strategy globally) is required.
- A Bachelor’s degree with at least 4 years of related regulatory affairs experience in a health regulated industry experience is required.
- International clinical and regulatory experience is desired.
Company: Johnson & Johnson
Vacancy Type: Full Time
Job Location: Sarasota, FL, US
Application Deadline: N/A