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Job Responsibilities:

​Regulatory expertise:

• Comprehensive knowledge of medical device regulations, such as FDA's 21 CFR Part 820 and ISO 13485.

• Understanding of global regulatory landscapes, including CE marking, Health Canada, TGA (Australia), and more.

• Awareness of upcoming regulatory changes and industry trends.

• Proficiency in crafting and overseeing risk management strategies aligned with regulatory standards.

• Demonstrated ability in risk assessment and the formulation of mitigation plans.

• Familiarity with tools like FMEA for in-depth risk analysis.

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Quality Assurance/Management:

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• Proven track record in developing and sustaining compliant Quality Management Systems (QMS).

• Experience with audit processes, CAPA management, and quality improvement methodologies like Lean and Six Sigma.

• Strong aptitude for generating, reviewing, and managing compliance documentation.

• Ensuring systematic and accurate record-keeping for regulatory audits and reviews.

• Proactive updating of documents in response to regulatory shifts

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Training Expertise/Interdepartmental Collaboration:

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• Ability to design and execute compliance training initiatives.

• Skill in identifying training gaps and ensuring workforce competency.

• Keeping training content updated with industry best practices.

• Effective communication skills to liaise with R&D, manufacturing, and quality teams.

• Experience in engaging with external entities like regulatory bodies and notified agencies.

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Project Handling/Problem-Solving Skill:

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• Competence in overseeing concurrent projects with an emphasis on compliance and timelines.

• Setting clear project milestones, resource allocation, and progress tracking.

• Proactively addressing project challenges and ensuring deliverables.

• Advanced analytical skills for interpreting and applying intricate regulatory requirements.

• Ability to pinpoint compliance gaps, assess risks, and devise solutions.

• Proficiency in root cause analysis and corrective action planning.

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Job Requirements:

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• BSc or higher in Medicine, Pharmacy, Engineering, Chemistry, Biochemistry or another scientific discipline.

• At least 2-3 years of Professional work experience in Regulatory affairs.

• Proven experience as compliance manager.

• In-depth knowledge of the industry’s standards and regulations.

• Excellent knowledge of reporting procedures and record keeping.

• Methodical and diligent with outstanding planning abilities.

• An analytical mind able to “see” the complexities of procedures and regulations.

• Excellent communication skills

• Ability to work independently and to handle complex tasks is an extra point.

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If you're interested kindly send your CV with the job title in the subject line on talent@clearxaligners.com