Medical Device Compliance Manager
1 week ago
As a Medical Device Compliance Manager at Mason Alexander, you will play a critical role in ensuring compliance with applicable regulations and standards for medical devices. You will develop and implement regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products.
Job DescriptionThe successful candidate will collaborate with cross-functional teams to ensure compliance with applicable regulations and standards while facilitating product commercialization and market access. You will also provide regulatory direction to development project teams, advise other functional units on requirements in each target market, and review proposed labeling/instructions for use for compliance with applicable local and international regulations.
You will have a strong understanding of regulatory procedures and changes, with the ability to keep abreast of emerging standards, theories, and methodologies. Additionally, you will possess excellent communication skills, with the ability to effectively communicate with external biological laboratories, consultant/toxicologists, and peer reviewers.
Key Responsibilities:
- Develop and implement regulatory strategies to support product registration, approval, and maintenance.
- Collaborate with cross-functional teams to ensure compliance with applicable regulations and standards.
- Provide regulatory direction to development project teams.
- Review proposed labeling/instructions for use for compliance with applicable regulations.
Required Skills and Qualifications
To be successful in this role, you will require:
- A Level 8 Honor's Degree in Science or Engineering.
- Minimum 3-5 years relevant experience with medical devices.
- Regulatory experience in Medical Devices, Pharmaceuticals, or similar regulated industry.
- Strong understanding of regulatory procedures and changes.
Benefits
We offer a dynamic and supportive work environment, with opportunities for professional growth and development. If you are a proactive and results-driven individual with a passion for regulatory affairs and compliance, please apply for this exciting opportunity.
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