Job Description

The Regulatory Affairs & Compliance Manager is responsible for developing, implementing, and maintaining regulatory affairs and quality system compliance programs to ensure continued compliance with applicable global regulations, standards, internal and customer requirements. This position provides regulatory affairs leadership and compliance oversight across manufacturing operations, supports regulatory inspections and external audits, and partners with cross-functional teams to ensure products and processes remain compliant throughout their lifecycle.

The role serves as a key liaison with regulatory authorities and certification bodies, while driving continuous improvement initiatives that strengthen the organization's compliance profile.

Regulatory Affairs:

• Develop and execute regulatory strategies that support business objectives and product lifecycle management as applicable to a Contract Manufacturer Organization (CMO).

• Ensure compliance with applicable global regulations, including FDA, ISO 13485, ANVISA, PMDA, and other international regulatory requirements, as applicable.

• Maintain establishment registrations, globally.

• Support customer regulatory requests.

• Provide regulatory guidance for new product introductions, design changes, manufacturing transfers, and process changes.

• Review regulatory documentation as required.

• Maintain Drug Mater Files.

• Assess regulatory impact of engineering changes and manufacturing modifications.

Compliance:

• Ensure the Quality Management System remains compliant with applicable regulations and standards.

• Develop, implement, and maintain regulatory compliance procedures and policies for the site.

• Monitor compliance metrics and report key performance indicators to leadership.

• Lead quality system compliance initiatives and continuous improvement projects.

• Support Management Review activities by providing regulatory and compliance performance data.

• Ensure effective implementation of corrective and preventive actions related to regulatory compliance.

• Lead site readiness for regulatory inspections and certification audits.

• Serve as primary regulatory representative during FDA inspections, certification body audits, and customer audits.

• Coordinate responses to regulatory observations, audit findings, and other regulatory communications.

• Track commitments and ensure timely completion of corrective actions.

• Ensure effective implementation of the internal audit program and regulatory compliance assessments.

• Identify regulatory compliance risks and develop mitigation strategies.

• Promote a culture of compliance and continuous improvement.

• Support harmonization and standardization of regulatory and quality system processes.

• Support implementation of digital quality systems and regulatory technologies.

• Lead or participate in cross-site compliance projects

Cross-Functional Leadership:

• Partner with Quality, Operations, Engineering, Supply Chain, and other teams to ensure regulatory compliance throughout the product lifecycle within a CMO.

• Provide regulatory guidance during product development, validation, technology transfers, and process improvements.

• Lead or participate in cross-functional compliance projects.

• Mentor personnel and provide regulatory training across the organization.

Knowledge requirements:

• Thorough knowledge of:

  • ISO 13485

  • FDA Quality Management System Regulation (21 CFR Part 820/QMSR)

  • Medical Device Submissions

  • ISO 14971

  • Global medical device regulatory requirements

• Strong understanding of Quality Management Systems.

• Experience with CAPA, Nonconforming Product, Complaint Handling, Risk Management, Change Control, Internal Audits.

• Strong analytical and problem-solving abilities.

• Excellent regulatory writing and technical documentation skills.

• Effective project management and organizational skills.

• Excellent verbal and written communication skills.

• Ability to influence cross-functional teams without direct authority.

• Proficiency with electronic Quality Management Systems (eQMS), document management systems, and Microsoft Office applications.

Experience and Education:

Education:

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical discipline.

• Master's degree preferred.

Experience:

• Minimum 3 years of experience in Regulatory Affairs within the medical device industry.

• Minimum 6 years of experience in Quality Assurance, Quality Systems or Compliance within the medical device industry.

• Minimum of 3 years of experience conducting audits in the medical device industry (ISO 13485, Lead Auditor certification preferred).

• Minimum 3 years of leadership or management experience.

• Experience supporting Health Authorities inspections and/or external audits.

Preferred Certifications:

• Regulatory Affairs Certification (RAC)

• ASQ Certified Quality Auditor (CQA)

• ASQ Certified Quality Engineer (CQE)

• Exemplar Global Lead Auditor (ISO 13485)

• Lean Six Sigma Green Belt or Black Belt (preferred)

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