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Compliance Manager -

Medical Product  
(Hybrid, Cairo - Egypt)

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.

Quality Assurance/Management:

  • 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

Training Expertise/Interdepartmental Collaboration:

  • 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.

Project Handling/Problem-Solving Skill:

  • 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.

Job Requirements:

  • 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.

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

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