Regulatory Affairs Coordinator

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Job Description

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Regulatory Affairs Coordinator

Location: Palm Beach Gardens, Florida, USA

Function: Regulatory

We are ZimVie, a 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!

Job Summary:

Responsible for supporting international product registrations from headquarters, including processing of regulatory documentation, notarization and legalization of documents, and tracking and reporting on the status of global registrations. Reviews and processes export invoices and Regulatory Affairs' related invoices, coordinates the ordering of product samples, issues Certificates to Foreign Government (CFGs), and maintains control of electronic Instructions for Use (eIFUs). Provides general administrative and coordination support to the Regulatory Affairs department.

Principal Duties and Responsibilities:

• Process and coordinate documentation required for international product registrations, ensuring accuracy and completeness prior to submission.
• Coordinate notarization and legalization (e.g., apostille, consular legalization) of regulatory and corporate documents required for international markets.
• Process invoices related to Regulatory Affairs activities, including notary, legalization, and registration fees, for timely payment.
• Track and report on the status of international registrations, maintaining the RA registrations tracker and providing regular status updates to stakeholders.
• Review export invoices for accuracy and compliance with regulatory and shipping documentation requirements.
• Coordinate the ordering and shipment of product samples needed to support international registration submissions.
• Prepare and issue Certificates to Foreign Government (CFGs) as requested by international affiliates and distributors.
• Maintain control of electronic Instructions for Use (eIFUs), including version tracking and ensuring documents remain current and accessible.
• Provide general Regulatory Affairs coordination support, including other administrative and documentation tasks as assigned.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

• Possess previous office experience with proven ability to manage, organize and prioritize all the detailed aspects of several projects simultaneously.
• Ability to manage time-sensitive, multi-step documentation processes (e.g., notarization, legalization) with tact and professionalism when working with external parties.
• Excellent communication, both oral and written, and ability to work with employees at all levels of the organization, as well as external partners such as notaries, consulates, and international affiliates.
• Be self-motivated while working with minimal supervision and managing competing deadlines across multiple countries and time zones.
• Able to follow instructions and take direction from multiple sources with changing priorities.
• Must be detail oriented and possess ability to file/retrieve data and to assemble submissions in a quality manner.
• Ability to learn key activities related to the position and adapt to evolving international regulatory requirements.
• PC literate and demonstrate proficiency in Windows, Microsoft Office (Word, Outlook, Excel), and regulatory tracking/database applications.
• Administrative skills with ability to detect spelling, punctuation, and proofreading errors in regulatory documents.

Education/Experience Requirements

• Typically requires associate or bachelor's degree, or a combination of education and related experience will be considered.
• 1+ years of office, administrative, or regulatory affairs/international trade experience preferred.
• Familiarity with regulatory terminology, international registration processes, and medical device or pharmaceutical product knowledge is a plus
• Active Notary Public License is preferred.

Travel Requirements

Up to 5%

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, demotion, evaluation, compensation, and separation, are considered without regard to race, color, religion, religious beliefs, creed, national origin, ancestry, citizenship status, age, gender/sex (including pregnancy, childbirth, related medical conditions, lactation and breastfeeding), gender identity or expression (including transgender status), sexual orientation, marital status, military status, protected veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any other status protected under applicable federal, state and local laws.

ZimVie generally does not sponsor applicant work visas for this position.

• Requisition ID: 3567

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