Job Description

Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for a Director, Regulatory Affairs, Ethicon Biosurgery to be preferably based in Somerville, New Jersey or remote for the right candidate.

Ethicon, part of the Johnson & Johnson Medical Device Companies, has made significant contributions to surgery for more than 100 years, from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our surgical technologies and solutions include sutures, staplers, energy device, trocars, and hemostats along with interventional ablation, robotics, and digital solutions. The Ethicon Biosurgery platform includes various absorbable hemostats, absorbable adhesion barriers, and fibrin sealant products.

The Director, Regulatory Affairs, Ethicon Biosurgery is responsible for overseeing and directing a Regulatory Affairs team to ensure end-to-end global regulatory compliance, strategy development, and execution of regulatory affairs activities for Class II and Class III medical devices, drug-device-biologic combination products, and post-market compliance activities for biologics. The Director is responsible for assessing regulatory pathways and oversees the development of global regulatory strategic plans and regulatory submissions (PMA/510(k)/IDE/Design Dossier) required to obtain timely registration for new products and throughout the products life cycle. The Director is responsible for overseeing and ensuring achievement of MDR compliance for the Ethicon Biosurgery portfolio of medical devices. The Director also reviews and provides guidance on advertising and promotional practices, product labeling, and corporate communications and training.

The Director, Regulatory Affairs communicates and builds relationships with global regulatory agencies through strategy alignment, interactive submissions, audits, and policy development. The Director ensures that internal regulatory policies, procedures, and practices comply with appropriate global regulatory requirements. The Director provides robust regulatory guidance and recommendations to cross-functional partners, including research and development, supply chain, and commercial organizations, and various Ethicon leadership teams.

The Director, Regulatory Affairs identifies, prioritizes, allocates, and manages appropriate resources to successfully achieve strategic objectives and to maintain compliance. The Director continually assesses the current state of the department (organizational structure, competencies, and skills), and develops and implements a strategic vision and tactical plan consistent with the organizational and RA strategic objectives. The Director must inspire, motivate, and communicate vision to regulatory associates, peers, and various leadership teams, and builds consensus toward adoption of and commitment to new standards for the regulatory affairs department. Determines and develops regulatory competencies and skills needed for the future success of the business unit. Provides leadership, personnel development, training, coaching, and mentoring for staff.

Qualifications
* A minimum of a B.A. / B.S or undergraduate degree is required
* A scientific or technical discipline is an asset
* An Advanced degree (M.S., M.E., JD, PhD or MD) is preferred.
* Minimum of 12 years relevant/regulated industry experience is required.
* Minimum of 8 years of regulatory affairs experience is required.
* Previous experience with medical devices is preferred.
* Previous experience with combination products or biologics is an asset.
* A proven track record of developing and executing global regulatory strategies and submissions that align with business deliverables is required.
* Previous people management/leadership experience is required.
* This position is to be preferably based in Somerville, New Jersey or remote for the right candidate, and may require up to 10% international and domestic 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.

Primary Location
United States-New Jersey-Somerville-
Other Locations
United States
Organization
Ethicon Inc. (6045)
Job Function
Regulatory Affairs
Requisition ID
2105890328W