Our organization is seeking a Senior Regulatory Expert. This position involves supporting regulatory strategies and managing FDA-focused submissions to secure approvals for medical device sales.
Responsibilities include:
* Maintaining knowledge of global medical regulations, primarily FDA and EU (MDD 93/42/EEC).
* Benchmarking regulatory approaches with leadership.
* Pursuing and submitting FDA filings (510(k), HDE, IDE, PMA).
* Negotiating timely approvals with regulators.