Regulatory Compliance Specialist for Medical Devices in Europe
hace 6 días
We are ZimVie, a leading global life sciences company focused on restoring daily life to our patients. Our comprehensive portfolio of innovative solutions includes tooth replacement and spine surgery products.
About the role:
Job Description- Maintain regulatory compliance for products marketed by ZimVie with primary emphasis on communications with Competent Authorities.
The ideal candidate will have experience with medical devices or similar products, as well as fluency in English and Spanish. A university degree in a health or life science related subject is required, along with 4 years of practical international medical device regulatory and quality experience.
What you'll be doing:
Main Responsibilities- Participate in regulatory global submissions and maintain Health Authorities databases for Medical Device placing in the market and commercialization.
- Ensure the adequacy of all labeling and IFUs to international standards.
- Communicate updates to regulatory staff and participate in assessments of new or updated regulations and standards applicable to the products.
- Prepare change notifications to the notified body when required.
- Support the R&D team in design and development plans according to the global strategy, representing the RA department.
What we offer:
Benefits- A competitive salary estimated at $85,000 - $110,000 per year based on location and experience.
- An opportunity to work in a diverse and collaborative global team embracing innovative curiosity, personal authenticity, accountability, and a growth mindset.
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