Associate Director Regulatory Affairs M/F

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 position manages all facets of regulatory support to market ZimVie products such as the development of regulatory submissions provision of guidance and consultation for international regulations; interaction with governmental agencies and managing a staff of regulatory professionals. The position holder will contribute to the development of the Regulatory Affairs strategy.

What you’ll be doing:

• Directs regulatory submissions, including dossier development and electronic publication, ensuring compliance and timely approvals.
• Provides regulatory direction to project teams, defining strategies for new products and communicating them to the RA group.
• Oversees labeling, package inserts, promotional materials, and product changes for regulatory compliance.
• Interprets and applies regulations to business practices, offering strategic guidance to the organization.
• Establishes and ensures compliance with ZimVie RA policies and procedures, including training initiatives.
• Maintains communication on regulatory requirements, emerging issues, and interactions with regulatory agencies.

• Manages departmental priorities, overseeing tasks, projects, and the development of regulatory professionals.

What you’ll need:

• Degree in life sciences, technical (engineering), or related field. Advanced degree preferred.
• Regulatory Affairs Certificate and minimum of 5 years prior RA experience in Medical Device company, ideally in the Dental field.
• Experience in the areas of drug, biologics, and combination products regulations is also desirable.
• Team management experience, fostering collaboration and professional growth.
• Detail-orientation and high quality focus.
• Ability to assess business risks and develop regulatory strategies.
• Strong communication and negotiation skills, effectively engaging with Regulatory agencies, management, and cross-functional teams.
• Customer- and results-oriented mindset.

Travel Requirements

            Up to 25%

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:

• Competitive compensation package
• Permanent contract
• Meal allowance
• Partially remote work option available
• Private life, health and dental insurance
• Employee Assistance Program
• Learning & development program

Do you want to know more about us? Click HERE to watch our story.

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.

• Requisition ID: 3067