Regulatory Affairs Strategy Sr. Associate (m/f/d) – Medical Devices
467
Erlangen, Germany
Global medical device submissions experience
Eu mdr technical documentation expertise
Fda 510(k) and pma submission knowledge
This role supports the global regulatory strategy for the WaveLight portfolio, ensuring alignment with international requirements
Job Summary
This role supports the global regulatory strategy for the WaveLight portfolio, ensuring alignment with international requirements.
Candidates will prepare and coordinate regulatory submissions including registrations, renewals, and updates while collaborating with health authorities.
The position offers the opportunity to play a key role in the entire product lifecycle from innovation to market success within a dynamic team.
Matching Summary
This role supports the global regulatory strategy for the WaveLight portfolio, ensuring alignment with international requirements.
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
Health Canada regulatory pathways
Key Requirements
Degree in Life Sciences or related field
5+ years of global medical device submission experience