Manager, Regulatory Affairs


NeuroModulation Solutions, a member of Johnson Johnson's Family of Companies, is recruiting for a Manager, Regulatory Affairs, located in Somerville, NJ.

NeuroModulations Solutions is an exciting new program with a focus on neurostimilation. The venture operates as a separate small unit nested within the Global Surgery Medical Device Group of Johnson Johnson.

The Manager, Regulatory Affairs, under limited supervision, will be responsible for managing projects related to meeting Regulatory Affairs requirements on a worldwide basis, focusing on product registrations based on country specific regulations. S/he will be responsible for the preparation and submission of 510(k) s, PMAs, PMA Supplements, IDEs, Design Dossiers/Change Notifications and Technical Files (CE Mark) to support the multiple product lines.

Principle duties and responsibilities of this position include: Identifies, plans, develops strategies and applies regulatory requirements that permit the successful registration of products worldwide. Identifies, develops, and implements worldwide regulatory strategy initiatives based upon business needs. Identifies, develops, and implements innovative process initiatives that promote efficiency of worldwide registrations. Participate and provide guidance and support to senior management and product development teams. Reviews and analyzes ECOs, NCRs, manufacturing, and clinical protocol procedures and documents. Organizes project teams, initiates project schedule documentation and provides project leadership on a worldwide basis in order to achieve desired outcomes within timeframes defined. Will participate in new business development activities as needed. This position will require interaction with the U.S. FDA and other regulatory authorities around the world and will participate in audits and other applicable activities.

This position requires the participation on New Product Development Teams to provide regulatory guidance and to obtain rapid and timely approval of new products devices. Review and analyze technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance or other related departments.

Qualifications

A Bachelors Degree in a scientific discipline is required; a Master's or higher degree is preferred. A minimum of 8 years of business experience with at least 5 of those years working in a Regulatory Environment preparing submissions for complex Class II and/or Class III medical devices is required. The Manager must have the ability to link functional responsibilities to overall business goals, and to manage and prioritize multiple projects simultaneously. Experience preparing and submitting one or more of the following: 510K's, EU Design Dossiers, IDE's, PMA's and Annual Reports are required. Prior interaction with the FDA and other worldwide agencies is required. Experience with devices that contain software and electrical design is preferred. Experience working in a cross-functional environment and a complex regulatory environment is required. Candidate must have the ability to provide innovative solutions within the boundaries of regulation, have the ability to organize data and identify issues or gaps, and have the ability to effectively communicate in oral and written forms.

If you want to explore the many small-company environments behind the big-company impact of the Johnson Johnson Family of Companies, bid on this position today!