Regulatory Affairs Director
Regulatory Affairs Lead / Director
We are looking for an experienced Regulatory Affairs professional to guide US and EU regulatory strategy for a complex medical device.
What you will do
* Lead the full US market entry strategy including 510k, De Novo or PMA routes
* Run Q Sub and Pre Submission processes and prepare all submission documents
* Act as the main contact for the FDA and translate feedback into clear internal actions
* Integrate clinical evidence from Europe into US documentation
* Oversee a large technical file and ensure it meets FDA and EU expectations
* Work closely with Quality during the transition to ISO 13485 and MDR
* Support audits in Italy, the US and other sites
* Align regulatory activities with R&D, Quality and Manufacturing
* Lead a small regulatory and quality cluster
* Support regulatory planning for a growing pipeline
* Build scalable frameworks that support long term growth
What you bring
* Strong experience with US medical device pathways including 510k, De Novo and PMA
* Deep understanding of MDR, ISO 13485 and transitions from legacy systems
* Ability to work on complex borderline products
* Experience preparing or reviewing large technical files
* Calm under pressure and comfortable with shifting priorities
* Strong communication skills and ability to work with scientists, quality teams and leadership
* Hands on approach and willingness to travel internationally
* Professional maturity and interest in long term ownership of regulatory leadership
What you can expect
* High impact role with direct involvement in a US launch and global regulatroy strategy
* Young and committed European team with a direct communication style
* Competitive compensation
* Flexibility to be based anywhere in Europe with strong regulatory exposure
If this is you take the chance and apply now!
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