Regulatory Affairs Manager Healthcare in High Wycombe

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. We respect the diversity and dignity of our employees and recognize their merit.

Johnson & Johnson is currently seeking a Director, Enterprise Regulatory Compliance, to join our Enterprise Regulatory Compliance Assessment team located in High Wycombe, UK. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

The Director, Enterprise Regulatory Compliance reports to the Senior Director, Head of Assessment, Enterprise Regulatory Compliance, and serves as an enterprise point of contact for cGMP regulatory compliance matters across Medical Devices and Pharmaceuticals. This role provides independent oversight of compliance risks and trends, partners with Quality and Compliance, and Regulatory Intelligence leaders to identify and mitigate emerging risks and delivers clear insights to senior leadership to support sound, risk-based decisions.

• Serve as the Enterprise Regulatory Compliance Single Point of Contact and subject-matter leader for policy interpretation, issue triage, and decision support across pharmaceutical and medical device businesses.
• Provide independent assessments of manufacturing, quality, and compliance risks, supporting consistent application of global regulations, company standards, and policies across segments and sites.
• Independently review and classify Health Authority inspections and corporate cGMP audits to ensure consistency across businesses.
• Independently review and initiate issue management for health authority inspections and recalls across the pharmaceutical and medical device businesses following escalation policies and standards.
• Support inspection readiness activities in preparation for Health Authority and Notified Body audits and pre-approvals.
• Review US FDA response reviews, as assigned, to ensure completeness, quality, and alignment with applicable requirements.
• Analyze large volumes of regulatory compliance data to identify actionable insights and lead periodic data driven compliance reviews for senior executive leadership.
• Lead enterprise interpretation, oversight, and governance for significant compliance escalations, including alignment on required actions and communications to senior leadership.
• Participate, as needed, in corporate regulatory compliance audits, due diligence, and acquisition compliance assessments; provide consultative expertise on compliance issue management, including support for health authority responses and field action decisions in accordance with policy requirements.
• Provide cGMP training to corporate and internal audit teams on risk-based auditing strategies for key compliance issues and emerging trends.

The Director, Enterprise Regulatory Compliance is a highly visible role within the Quality and Compliance organization and requires expert global regulatory compliance knowledge and practical expertise across pharmaceuticals and medical devices.

A minimum of a bachelor's degree is required. Advanced degree in an applicable field of study or certification is preferred. A minimum of 10 years' relevant quality and compliance experience is required. Work experience for a Health Authority or Notified Body is preferred but not required. Prior work experience in cGMP regulatory compliance in medical device and/or pharmaceutical regulations is required. Strong written and oral communication skills that can be adapted to the appropriate levels of a large complex organization to facilitate regulatory compliance risk understanding is required. Track record of successful leadership skills in cGMP compliance is required. Up to 20% domestic and international travel may be required as business demands.

Summary Location: High Wycombe, Buckinghamshire, United Kingdom Type: Full time