Associate Director Regulatory Affairs M/F

hace 2 semanas

Cornellà de Llobregat, Barcelona, España ZimVie Inc. A tiempo completo
Associate Director Regulatory Affairs M/F

Job Function: Regulatory

Location: Cornella de Llobregat, B, ES

Welcome to ZimVie

Welcome to ZimVie, a new, publicly traded global company focused on improving quality of life for our patients. Our company is founded on a legacy of established brands, medical experts and over $1B in annual revenue. We design, manufacture, and distribute a comprehensive portfolio of innovative solutions for implant dentistry, spinal surgery and bone growth stimulation. Our seasoned leadership and dedicated global team of more than 2,500 is focused on shaping an exciting future for ZimVie — 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
  • Partially remote work option available
  • Private life, health and dental insurance
  • Employee Assistance 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.

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