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J&J Family of Companies Associate Director, Regulatory Affairs in Somerville, New Jersey

Ethicon, Inc., a member of Johnson & Johnson Family of Companies, is currently recruiting for an Associate Director, Regulatory Affairs to be based in Raritan, NJ or remote for the right candidate.

Ethicon , part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com .

The Associate Director, Regulatory Affairs for Ethicon’s Biosurgery business unit will be responsible for partnering with R&D and Global Strategic Marketing platform leaders as well as other cross-functional team members/leaders to develop and execute global regulatory strategies to drive pipeline development and global launch excellence. Products supported are considered significant-risk medical devices worldwide to address a range of surgical challenges related to bleeding and sealing (e.g., Class II and Class III devices in the US). This role may also support combination product strategy (i.e., biologics/medical device) in a limited capacity. Primary responsibilities will include the development and execution of regulatory strategies to obtain market access for new/modified products and lifecycle management activities required to maintain existing products globally. The Associate Director is also responsible for evaluating the impact of current and emerging standards and regulations and determining the most effective and efficient strategies for obtaining or maintaining product clearances/approvals/registrations in key markets.

Position duties & responsibilities:

  • Act as a strategic partner with colleagues in R&D, Preclinical Research, Clinical Development, Global Strategic Marketing, Supply Chain, and Health Economics Market Access teams to develop and execute global regulatory strategies for new and existing products to assure on-time regulatory approval/clearance and post-marketing activities with a focus on strategic markets.

  • Demonstrate a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products.

  • Develop and submit US and EU regulatory filings such as Pre-submissions, IDEs, PMAs, 510ks, and Design Dossier/Technical Files. Partner with regional leaders on regulatory strategy and submissions to successfully obtain marketing approvals for all other markets.

  • Lead Health Authority meetings for key markets and interact with Health Authorities regarding product regulatory filings.

  • Partner with regional leaders and the Regulatory Affairs Policy Intelligence team to monitor the regulatory environment globally and assess and communicate the impact of current and emerging regulations on the company's portfolio of products, define the future vision, and drive innovative thinking.

  • Integrate changing, complex, and/or ambiguous information for effective decision-making and clearly communicate challenges and solutions to stakeholders to achieve strategic and/or project goals.

  • Review product design, labeling, and manufacturing changes to existing products to assess the impact to safety and efficacy.

  • Collaborate with Legal and Quality partners regarding product safety and quality issues. Contribute to risk management plans and failure mode analysis during product development and safety signal detection and post- market surveillance post-launch.

  • Apply Regulatory knowledge of competitor products, strategies, and market segmentation to help find opportunities and potential Regulatory challenges.

  • Manage, oversee and balance resource allocation across critical projects.

  • Provide key input for product claims and evidence support, and review and approve Advertising and Promotional materials in accordance with local regulations.

  • Lead, inspire, and mentor RA staff members, directly or indirectly.

  • Influence and collaborate to bring about process and technical improvements within the organization.

  • Represent the company and influence regulations and health authority guidance through industry trade association(s) in partnership with the Policy Intelligence team.

  • Ensure that company policies, procedures and practices are in compliance with appropriate regulatory requirements.

Qualifications

  • Bachelor’s degree is required. Advanced degree is a plus. Degree in a technical related discipline is preferred.

  • Minimum 10 years relevant / regulated industry experience is required or 7 years with an advanced degree.

  • Previous experience with medium and high-risk medical devices (including regulatory submissions) is strongly preferred. Previous experience with combination product is a plus.

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

  • Experience working closely with and negotiating with Health Authorities is preferred.

  • Experience working with professional and trade associations is a plus.

  • The position is preferred to be located in Raritan, NJ or can be remote for the right candidate.

    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

United States-New Jersey-Somerville-

Other Locations

United States-New Jersey-Raritan

Organization

Ethicon Inc. (6045)

Job Function

Regulatory Affairs

Requisition ID

2105961153W

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