Position
Associate Director, Regulatory Policy (Regulatory Affairs / Compliance)
Locations
- Zuchwil, Switzerland – Requisition Number: R-074453
- Diegem, Belgium – Requisition Number: R-077643
- Blackpool or Leeds, United Kingdom – Requisition Number: R-077646
- MA RAYNHAM, FL, PALM BEACH GARDENS, PA, WEST CHESTER, United States – Requisition Number: R-077651
Overview
As Associate Director, Regulatory Policy, you will provide leadership and subject‑matter expertise in regulatory policy and compliance, supporting the development, interpretation, and implementation of global and regional regulatory requirements for DePuy Synthes.
Key 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.
Qualifications
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, Law, or related discipline (required)
- Advanced degree or professional certification in Regulatory Affairs or Compliance (preferred)
Professional Experience and Skills
- Typically 8–10 years of progressive experience in regulatory affairs, regulatory policy, or compliance within a regulated industry (required)
- 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
- Experience in medical devices, healthcare, or other highly regulated industries (preferred)
- Exposure to regulatory inspections, audits, or authority interactions (preferred)
- Experience working in a global or matrixed organization (preferred)
- Demonstrated success driving regulatory or compliance process improvements (preferred)
- Familiarity with US, EU MDR, China, and other major international regulatory frameworks (preferred)
- Effective written and verbal communication skills
- Strong analytical, problem‑solving, and documentation skills
Additional Requirements
- Language: English required; additional European languages preferred
- Travel: Limited; occasional international travel as needed
- Certifications: RAC or equivalent preferred but not required
Required Skills
- Analytical Reasoning
- Business Writing
- Compliance Risk
- Fact‑Based Decision Making
- Industry Analysis
- Legal Support
- Mentorship
- Organizing
- Product Licensing
- Public Policies
- Regulatory Affairs Management
- Regulatory Compliance
- Regulatory Development
- Regulatory Environment
- Risk Assessments
- Strategic Thinking
- Technical Credibility
Preferred Skills
- Analytical Reasoning
- Business Writing
- Compliance Risk
- Fact‑Based Decision Making
- Industry Analysis
- Legal Support
- Mentorship
- Organizing
- Product Licensing
- Public Policies
- Regulatory Affairs Management
- Regulatory Compliance
- Regulatory Development
- Regulatory Environment
- Risk Assessments
- Strategic Thinking
- Technical Credibility
Equal Opportunity and Accessibility Statement
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. Johnson & Johnson actively seeks qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us at https://www.jnj.com/contact-us/careers; internal employees contact AskGS to be directed to your accommodation resource.
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