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TEMP Regulatory Affairs Specialist EMEA
hace 1 semana
We are ZimVie, a renowned global player in life sciences dedicated to enriching daily life through advancements in clinical technology, enhancing patients' smiles, functionality, and confidence. Our company prides itself on a rich heritage of trusted brands, products, and scientific backing, fostered by an inclusive and collaborative environment that encourages our team members to bring their authentic and top-notch selves to work every day to fulfill our Mission. Together, our diverse and dedicated global team is paving the way for an exciting future at ZimVie— we invite you to consider joining us.
About the role:
Responsibilities include maintaining, updating, or creating Technical documentation (TD) and FDA submissions in alignment with the company's global strategy. This position offers a hybrid work setup and is based in Spain.
What you'll be doing:
- Support the MDR transition project for Dental products by updating TD to comply with EU MDR.
- Participate in preparing TD documents.
- Contribute to assessing new or revised regulations and standards for products as needed.
- Attend Management Reviews meetings for the Palm Beach Gardens site when necessary.
- Prepare change notifications for the notified body when required.
- Assist in production transfers and Operational Projects as necessary.
- Support the R&D team in designing and planning development in line with global strategy, serving as the RA department representative.
- Participate in internal and external audits upon request.
- Support other projects as needed.
What you'll need:
- University degree in health or life science related field.
- 1-2 years' experience in EU MDR CE mark and Technical Documentation preparation.
- Proficiency in English & Spanish; knowledge of other European languages is a plus.
- Skilled in MS Office.
- Attention to detail, initiative, flexibility, comfortable with deadlines, and ability to work under pressure.
What we offer:
Join a diverse and collaborative global team that values innovative thinking, authenticity, accountability, and a growth mindset. Our culture encourages us to bring our true selves to work daily, enabling us to deliver top-notch service to our customers, patients, and colleagues.
At ZimVie, you'll have the opportunity for a challenging role with promising career growth in the international medical device sector along with the following benefits:
- 1-year temporary contract.
- Competitive compensation package.
- Meal allowance.
- Partial remote work option.
- Dynamic international work environment.
Are you intrigued? Submit your application online with your cover letter, CV, and references through our official website. We are excited to review your application.
ZimVie is an Equal Opportunity Employer dedicated to fostering diversity and inclusivity in the workplace. We make all employment-related decisions without bias towards race, gender, religion, disability, age, or sexual orientation.
- Requisition ID: 2551
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