Regulatory Affairs Strategy Sr. Associate (m/f/d) – Medical Devices

Alcon

Erlangen, Germany
Global medical device submissions experience
Eu mdr technical documentation expertise
Fda 510(k) and pma submission knowledge
This role supports the regulatory strategy for the Wavelight portfolio to ensure global product approvals

Job Summary

  • This role supports the regulatory strategy for the Wavelight portfolio to ensure global product approvals.
  • Candidates will prepare and coordinate regulatory submissions including registrations, renewals, and updates for innovative eye care technologies.
  • The position offers the opportunity to play a key role in the entire product lifecycle from innovation to market success within a global leader.

Matching Summary

This role supports the regulatory strategy for the Wavelight portfolio to ensure global product approvals.

Skills & Requirements

Must-have

  • Global medical device submissions experience
  • EU MDR technical documentation expertise
  • FDA 510(k) and PMA submission knowledge
  • Fluency in English and German languages
  • Promotional material compliance review

Nice-to-have

  • Cross-functional collaboration skills
  • Strong attention to detail
  • Commitment to continuous learning
  • Experience with ISO standards
  • Ability to manage multiple deadlines

Key Requirements

  • Degree in Life Sciences or related field
  • 5+ years of global medical device submission experience
  • Fluency in written and spoken German and English

Work Rights

Not specified

Tailored Resume

Cover Letter