Medical Device Compliance Specialist
1 week ago
Medtronic - A Career that Impacts Lives
We are seeking a highly skilled Medical Device Compliance Specialist to join our team.
About the Role
This is a critical position responsible for ensuring compliance with regulatory requirements and guidelines related to medical devices. The successful candidate will have a strong background in quality assurance, regulatory experience, and excellent analytical skills.
Key Responsibilities
- Evaluate and classify product complaints related to medical devices, including review of technical product analysis information provided by the plant.
- Determine reportability of complaints to government agencies, such as the FDA.
- Maintain accurate records in electronic databases and provide analysis and trending data on complaints.
- Liaise with cross-functional teams, including Technical Services, Manufacturing, R&D, and Quality Assurance.
- Provide technical expertise and assistance in handling complaints to ensure compliance with current regulations.
Requirements
- Bachelor's degree in a relevant field, such as Engineering or Science.
- 4-8 years of experience in quality assurance or regulatory roles within the medical or pharmaceutical industry.
- Excellent communication and analytical skills, with ability to multitask and work in a team environment.
- Strong typing skills and ability to write business documents with minimal supervision.
What We Offer
As a Medical Device Compliance Specialist at Medtronic, you can expect a competitive salary range of $85,000-$110,000 per year, depending on experience, plus a comprehensive benefits package and opportunities for professional growth and development.
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