Compliance Manager - Medical Devices

Job Description

• Comprehensive knowledge of medical device regulations, such as FDA's 21 CFR Part 820 , ISO 13485 , and EU MDR 2017/745 .
• Extensive experience in navigating regulatory requirements specific to medical devices, including pre-market approval processes, clinical evaluations, technical documentation, and post-market surveillance.
• Deep understanding of global medical device regulatory landscapes, including CE marking , Health Canada , TGA (Australia) , and others.
• Awareness of upcoming regulatory changes, such as updates to FDA guidance, ISO standards, or the EU MDR, and an ability to quickly adapt compliance strategies to meet new requirements.
• Proficiency in risk management strategies for medical devices, including risk assessment, mitigation plans, and adherence to regulatory standards.
• Familiarity with tools like FMEA (Failure Mode Effects Analysis) for in-depth risk analysis and ensuring regulatory compliance.

• Proven experience in developing and sustaining compliant Quality Management Systems (QMS) for medical devices, aligned with FDA , ISO 13485 , and EU MDR 2017/745 .
• Expertise in medical device audit processes, including internal and external audits, CAPA (Corrective and Preventive Action) management, and the application of Lean and Six Sigma quality improvement methodologies.
• Skilled in generating, reviewing, and managing compliance documentation for regulatory audits, inspections, and reviews in the medical device industry.
• Proactive updating of documents and records in response to evolving medical device regulations and industry standards, ensuring readiness for FDA inspections and other global audits.

• Ability to design and execute training programs that ensure medical device regulatory compliance, covering areas like FDA standards, ISO 13485, and EU MDR 2017/745 .
• Experience identifying training gaps, ensuring that teams stay informed on regulatory changes, and maintaining workforce competency in medical device manufacturing, quality assurance, and R&D.
• Strong communication skills to collaborate with cross-functional teams such as R&D, manufacturing, quality, and regulatory affairs to ensure seamless compliance across departments.
• Proficient in liaising with external entities like Notified Bodies , regulatory authorities, and other relevant agencies in the medical device sector.

• Competence in overseeing multiple medical device projects with an emphasis on regulatory compliance, timelines, and budget management.
• Proven ability to set clear project milestones, track progress, and allocate resources efficiently to meet regulatory deadlines for market entry or updates.
• Experience in proactively addressing project challenges, particularly those related to regulatory hurdles, ensuring deliverables like technical documentation, clinical evaluations, and risk assessments are met.
• Strong analytical skills in interpreting complex medical device regulatory requirements and implementing strategies for effective compliance.
• Expertise in identifying compliance gaps within medical device projects, assessing risks, and developing corrective action plans to address regulatory non-compliance.

Job Requirements

• BSc/BA or higher in Medicine , Pharmacy , Engineering , Chemistry , Biochemistry , or a related scientific discipline.
• At least 2-3 years of professional work experience in Regulatory Affairs , with a specific focus on medical devices and relevant regulations, such as FDA 21 CFR Part 820 , ISO 13485 , and EU MDR 2017/745 .
• Proven experience as a Compliance Manager in the medical device industry, with direct involvement in managing regulatory submissions, audits, and compliance documentation.
• In-depth knowledge of medical device regulatory standards and requirements, including the FDA, EU MDR , ISO 13485, and other global standards.
• Experience with regulatory reporting procedures and maintaining records for medical device audits and inspections.
• Strong methodical and diligent approach to planning and managing compliance activities.
• Ability to analyze and navigate complex regulatory frameworks specific to medical devices and contribute to the overall compliance strategy.
• Excellent communication skills for collaborating with cross-functional teams and external stakeholders.
• Ability to work independently, handle complex medical device compliance tasks, and contribute to continuous improvement initiatives.