Lead medical device compliance specialist

Regulatory Affairs Specialist

The Senior Regulatory Affairs Lead is responsible for developing and executing regulatory strategies to ensure compliance with medical device regulations.

* Developing comprehensive regulatory plans
* Coordinating with internal stakeholders to gather necessary information for submissions

To be successful in this role, candidates should have a strong understanding of the FDA's 21 CFR Part 820 and experience working with medical devices.


In addition to their technical expertise, ideal candidates will possess excellent communication skills and the ability to work effectively across departments.
The selected candidate will play a key role in maintaining our position as industry leaders by ensuring adherence to regulatory guidelines.

* Bachelor's degree in a life science or related field; Master's degree preferred.

* A minimum of five years of experience in regulatory affairs, preferably within the medical device industry.

litwo-three direct reports; may require management oversight from other team leads/ directors.}

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