Massachusetts Green Jobs

Senior Regulatory Affairs Program Lead - 2406183653W

Description

Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Regulatory Affairs Program Lead , to be located in Cincinnati, Ohio; Raynham, MA; Raritan, NJ or Santa Clara, CA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at _https://www.jnj.com/._

The Senior Regulatory Affairs Program Lead executes the Regulatory Affairs platform strategy. We support regional and country product registrations, monitor and assess impacts of product specific regulations for new products as well as lifecycle product registrations.

In this role, you will:

• Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified global product launches and related regulatory activities.

• Complete the preparation and submission of regulatory information required to obtain global market access, identifying risk and issues, effectively communicating timelines for project completion, and addressing issues that may impact registration status.

• Execute on plans that directly impact the operational results.

• Work closely with Research and Development, Medical Affairs, Quality Engineering, Product Management, Labeling, as well as global Regulatory Affairs affiliates.

• Support clinical strategy and work with clinical teams to support regulatory submissions.

Qualifications

• A minimum of a B.A. /B.S. within a technical related discipline is required

• A minimum of 6 years relevant / regulated industry overall experience is required

• A minimum of 4 years of medical device regulatory experience is required

• Experience in medical devices containing software and electrical testing highly preferred

• A demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required

• Working knowledge and thorough understanding of how global regulations impact product registration is required

• Experience with US and EU submissions required

• Strong written & verbal communication and presentation skills is required

• Collaborative work style in a highly matrixed environment is required

• The ability to build and sustain productive partnerships across multiple platforms is required

• The ability to evaluate new regulatory requirements as well as regulatory changes, and correctly assess business impact is preferred

• Plan and execute complex projects through timely completion is required

• The team will be based in Cincinnati, Ohio so this role may require up to 20% travel to other J&J MedTech sites

This job posting is anticipated to close on 5.27.2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $90,000 to $130,000. For Santa Clara, CA the anticipated base pay range for this position is $ 105,000 to $145,000. The pay range is the anticipated pay range for the position to which you have applied, and that such factors, including but not limited to, internal equity and experience will be considered for any offer.

Additional information can be found through the link below. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location NA-US-Ohio-Cincinnati

Other Locations NA-US-California-Santa Clara, NA-US-New Jersey-Raritan, NA-US-Massachusetts-Raynham

Organization Ethicon Endo Surgery Inc (6041)

Job Function Regulatory Product Submissions and Registration

Req ID: 2406183653W