Senior Regulatory Affairs Specialist for Medical Devices
hace 13 horas
We are ZimVie, a global leader in life sciences focused on restoring daily life to patients by designing innovative medical solutions. Our company is founded on a legacy of trusted brands and clinical evidence made possible through an inclusive culture that empowers our team members to bring their best selves to work every day.
About the RoleAs a Senior Regulatory Affairs Specialist, you will lead and prepare technical documentation, including biocompatibility, clinical, and post-market surveillance reports. You will also assist the Global Regulatory Affairs Manager with topics related to clinical affairs, regulatory compliance, and regulatory affairs.
- To prepare CERs for Technical Documentations
- To prepare post-market surveillance reports
- To prepare biocompatibility reports
- Maintain and prepare Technical Documentations according to EU MDR requirements
- Review new regulatory requirements and implement them accordingly
You will be responsible for:
Key Responsibilities- Support QMS maintenance, including alignment with ZimVie's Quality Management System
- Assist R&D in the development of new products
- Prepare and submit 510(k) documents
- Participate in External and Internal audits
To be successful in this role, you will need:
- A University degree in a Science-related subject (e.g., Biology, Biotechnology, Pharmacy)
- At least 5 years' experience in a similar position
- Proficiency in ISO 10993, ISO 14155, ISO 13485, EU MDR implementation, and FDA 21 CFR 820
- Excellent communication and organizational skills
- Fluency in English; other European languages are a plus
ZimVie offers a competitive compensation package, including:
- An estimated salary of $120,000 per year, based on industry standards and location
- A permanent contract
- A meal allowance
- Partially remote work option
- Private life, health, and dental insurance
- A learning and development program
We are an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions are considered without regard to racial or ethnic origin, gender, religion or belief, disability, age, or sexual identity.
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