Associate Director, Regulatory Policy
About The Position
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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 within 18 to 24 months, 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 plans. In 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 Associate Director, Regulatory Policy, Compliance/Policy provides leadership and subject‑matter expertise in regulatory policy and compliance, supporting the development, interpretation, and implementation of global and regional regulatory requirements. This role plays a key part in shaping regulatory policy positions, ensuring consistent compliance, and enabling informed decision‑making across the organization. The position partners closely with Regulatory Affairs, Quality, Legal, and business stakeholders to proactively manage regulatory risk and support sustainable business operations.
Requirements
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, Law, or a related discipline (required).
- Typically 8–10 years of progressive experience in regulatory affairs, regulatory policy, or compliance within a regulated industry.
- Strong understanding of global regulatory frameworks and policy development.
- Experience interpreting regulations and translating requirements into practical guidance.
- Proven ability to influence and advise senior stakeholders on regulatory policy matters.
- English required; additional European languages preferred.
- Effective written and verbal communication skills.
- Strong analytical, problem‑solving, and documentation skills.
Nice To Haves
- Advanced degree or professional certification in Regulatory Affairs or Compliance (preferred).
- Experience in medical devices, healthcare, or other highly regulated industries.
- Exposure to regulatory inspections, audits, or authority interactions.
- Experience working in a global or matrixed organization.
- Demonstrated success driving regulatory or compliance process improvements.
- Familiarity with US, EU MDR, China and other major international regulatory frameworks.
- RAC or equivalent preferred but not required.
Responsibilities
- Lead regulatory policy and compliance activities, ensuring alignment with applicable global, regional, and local regulatory requirements.
- Interpret evolving regulatory policies and guidance and assess impact on products, processes, and business strategies.
- Develop and maintain internal regulatory policies, standards, and guidance documents.
- Provide expert regulatory policy advice to cross‑functional stakeholders, including Regulatory Affairs, Quality, and business leaders.
- Support regulatory inspections, audits, and assessments related to policy and compliance topics.
- Monitor regulatory trends and emerging requirements, proactively identifying risks and opportunities.
- Partner with global and regional teams to drive consistent application of regulatory policies.
- Contribute to continuous improvement initiatives to strengthen regulatory compliance and governance frameworks.
Benefits
- Inclusive work environment
- Respect for diversity and dignity
- Recognition of merit
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
