Global Regulatory Compliance Specialist for Medical Devices
hace 3 semanas
We are ZimVie, a leading global life sciences company focused on restoring daily life to our patients through innovative medical device solutions. Our mission is to design, manufacture, and distribute high-quality products that meet international standards.
About the Role: This specialist will be responsible for ensuring regulatory compliance for our medical devices in the European market. Key duties include preparing and maintaining technical documentation, participating in production transfers and new product development, and communicating with Competent Authorities.
Responsibilities:
- Participate in regulatory global submissions
- Maintain and update Health Authorities databases for Medical Device placements in the market and commercialization
- Provide requested documents to subsidiaries and distributors as needed
- Ensure labeling and Instructions for Use (IFUs) adhere to International Standards
- Assess new or updated regulations and standards applicable to our products
- Communicate updates to regulatory staff
- Prepare change notifications to notified bodies when required
- Support production transfers and Operational Projects plans
What You'll Need:
A university degree in health or life science related subject and 4 years of practical experience in medical device regulatory and quality roles. Fluency in English and Spanish is essential. Certification as a Quality Auditor (CQA) is preferred. Proficiency in MS Office is also required.
Salary Range: $80,000 - $120,000 per annum, depending on qualifications and experience. We offer a competitive benefits package, including health insurance, retirement plan, and paid time off.
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