Sr. Director, Regulatory Law, Orthopedics

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DePuy Synthes is recruiting for a Sr. Director Regulatory Law located in Raynham MA New Brunswick New Jersey West Chester Pennsylvania.

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed sometime in 2027 subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

The Sr. Director Regulatory Law serves as a strategic legal leader supporting the global regulatory activities of DePuy Synthes across the orthopedic medical device and technology portfolio. This role provides expert legal counsel on complex regulatory matters partners closely with Regulatory Affairs Quality R&D and Commercial teams and helps shape regulatory strategy to enable innovation compliance and sustainable growth. This is a highly visible role with significant impact on product development lifecycle management and global market access.

Key Responsibilities:

• Serve as the senior legal advisor on U.S. and global regulatory law matters affecting medical devices and medical technology across the DePuy Synthes portfolio.

• Provide strategic legal counsel on regulatory submissions product clearances and approvals postmarket surveillance field actions including recalls and enforcement actions.

• Partner with Regulatory Affairs and Quality leadership to interpret and apply FDA EU MDR/IVDR and other global regulatory requirements.

• Serve on Quality Review Boards.

• Advise on regulatory aspects of product development clinical investigations labeling advertising and promotional activities including copy review.

• Advise on commercial activities including relating to risk of off-label promotion or activities prior to product clearance or approval.

• Lead regulatory legal risk assessments and develop mitigation strategies aligned with business objectives.

• Participate in due diligence for deal activities in order to assess regulatory compliance or risk associated with the transaction.

• Support global inspections audits and interactions with regulatory authorities including preparation and response strategies.

• Advise on responses to any regulatory bodies with respect to audit findings including observations or warning letters.

• Lead or participate in communications with enforcement bodies on a variety of issues.

• Monitor regulatory developments globally and advise the business on any necessary action or change to policy or procedure.

• Develop and deploy overarching strategy for interacting with and influencing regulatory policy and collaborating with Government Affairs colleagues on those strategies.

• Supervise paralegal providing support for cross-functional copy approval.

Education

• Juris Doctor (JD) from an accredited law school (required).

• Admission to practice law in at least one U.S. jurisdiction (required).

Experience and Skills:

Required:

• Typically requires 12-14 years of progressive legal experience including significant experience in regulatory law with a private law firm enforcement body or within a medical device medical technology life sciences healthcare company or in another highly regulated industry.

• Deep knowledge of FDA regulations and global medical device regulatory frameworks (e.g. EU MDR).

• Global regulatory experience including collaborating with in-house or outside counsel internationally.

• Experience supporting regulatory inspections enforcement actions or major product remediation activities.

• Demonstrated experience advising senior leaders on complex regulatory and compliance matters.

• Proven ability to balance legal risk with business strategy in a fastpaced environment.

• Strong communication skills and ability to influence senior executive decision making.

Preferred:

• Prior inhouse legal experience supporting a global medical device medtech organization.

• Familiarity with regulatory guidelines on digital health software as a medical device (SaMD) robotics biologics combination products or artificial intelligence.

• Experience supporting mergers acquisitions or corporate separations in a regulated environment.

• Strong leadership skills with experience collaborating with colleagues in different legal environments.

Other

• Language: English (required); additional languages preferred.

• Travel: Up to 1525% domestic and international.

• Certifications: None required.

• For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

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The anticipated base pay range for this position is :

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