Manager, Technical Regulatory Compliance
HybridPalm Beach Gardens, Florida, United States or Warsaw, Indiana, United States
Job Summary
Lead and manage technical regulatory compliance activities aligned with global strategies, providing oversight for technical processes, systems, and documentation supporting regulated activities. Interpret regulatory and technical standards into actionable requirements, partner with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams, and support internal, external audits, and health authority inspections. Monitor compliance risks and trends to drive corrective and preventive actions, ensuring consistent application of global and site-specific policies while leading continuous improvement initiatives. This role requires a Bachelor's degree in Regulatory Affairs, Quality, Engineering, or Life Sciences with 6-8 years of progressive experience in a regulated industry, located in Raynham MA, Palm Beach Gardens FL, or West Chester PA.
Required Qualifications
- Bachelor's degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Information Systems, or a related discipline
- 6-8 years of progressive experience in Regulatory Compliance, Quality Systems, Engineering, or related roles within a regulated industry
- Strong working knowledge of regulatory and technical requirements impacting quality systems and manufacturing processes
- Experience supporting audits, inspections, and regulatory assessments
- Ability to manage complex technical compliance topics across cross-functional stakeholder groups
- Strong analytical, risk-management, and problem-solving skills
- Effective written and verbal communication skills
- English language proficiency
Desired Qualifications
- Advanced degree in a scientific, regulatory, or technical field
- Experience in medical devices, healthcare, or other highly regulated industries
- Familiarity with U.S. regulatory and technical compliance frameworks
- Experience working in a global or matrixed organization
- Exposure to regulatory inspections involving technical or system compliance
- Quality or Regulatory certifications (e.g., RAC, ASQ)
- Limited; occasional domestic travel
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