We are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life to our patients by designing, manufacturing, and distributing a comprehensive portfolio of innovative tooth replacement and spine surgery solutions.
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, and we hope you'll consider being a part of it!
About the role: This role will be responsible for performing duties to maintain regulatory compliance for products marketed by ZimVie, with a primary emphasis on communications with Competent Authorities.
Responsibilities include the preparation and maintenance of Technical Documentation and participation in production transfers and new product development.
What you'll be doing: Participate in regulatory global submissions.
Maintain and update Health Authorities databases for Medical Device placing in the market and commercialization, as well as international internal databases on registrations.
Provide requested documents to each subsidiary/distributor on a case-by-case basis and in accordance with national laws.
Ensure the adequacy of all labeling and IFUs to international standards.
Participate in the assessments of new or updated regulations and standards applicable to the products, and national laws for any new or updated revisions.
Communicate updates to regulatory staff.
Participate in the preparation of the technical documentation.
Prepare change notifications to the notified body when required.
Participate in production transfer and operational project plans as needed.
Support the R&D team: Support the R&D team in the design and development plans according to the global strategy, representing the RA department.
Support quality audits.
Support the maintenance and improvements of the QMS related to the subsidiaries and distributors based on ISO 13485:2016 for dental products.
Participate, if requested, in internal and external audits and any responses to cited issues, owning corrective actions stemming from these audits.
Answer market requests related to QARA topics.
Perform regulatory/quality training for employees as well as subsidiary contacts.
What you'll need: University degree in health or life science related subject.
4 years of practical international medical device regulatory and quality experience.
Experience with medical devices or similar is preferred.
Certified Quality Auditor (CQA) preferred.
Fluent in English & Spanish.
Other languages are a plus.
Proficient in MS Office.
What we offer: Working in a diverse and collaborative global team embracing innovative curiosity, personal authenticity, accountability, and a growth mindset.
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