- Support the MDR transition project for Dental products by updating the TD to be in compliance with the EU MDR.
- Participate in the preparation of the TD documents.
- Participate in the assessments of the new or updated regulations and standards applicable to the products, upon request.
- Participate in the Management Reviews meetings for the Palm Beach Gardens site when required.
- Preparation of change notifications to the notified body when required.
- Participate in the production transfer and Operational Projects plans as needed.
- Support to the R&D team in the design and development plans according to the global strategy, representing the RA department with the team.
- Participation in internal and external departmental audits upon request.
- Support in any other projects upon request.
- University degree in health of life science related subject.
- 1-2 years of experience in EU MDR CE mark, preparing Technical Documentation.
- Fluent in English & Spanish. Other European languages is a plus.
- MS Office
- Attention to detail, initiative, and flexibility, used to work with deadlines, stress resistant.
- Temporary contract of 1 year
- Competitive compensation package
- Meal alowance
- Partially remote work option available
- PrivateInternational work environment
- Requisition ID: 2551
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TEMP Regulatory Affairs Specialist EMEA - Cornellà de Llobregat, España - ZimVie US Corp LLC
Descripción
We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life by advancing clinical technology to improve patients' smiles, function, and confidence. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves – their best selves – to work every day to accomplish our Mission. Together, our dedicated, diverse global team is shaping an exciting future for ZimVie — we hope you'll consider being a part of it
About the role:
Maintaining, updating or creating Technical documentation (TD) and FDA submission according to the Global strategy of the company.
What you'll be doing:
What you'll need:
What we offer:
Working in a diverse and collaborative global team embracing innovative curiosity, personal authenticity, accountability, and a growth mindset. Our culture empowers us to bring our whole selves to work each day, so we can be at our best when serving our customers, patients, and colleagues.
ZimVie offers you a challenging position with good career prospects in an international medical device business and following benefits:
Are you interested? Apply online enclosing your cover letter, CV and references via our homepage. We look forward to receiving your application
ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, etc. are considered without regard to racial or ethnic origin, gender, religion or belief, disability, age, or sexual identity.
