Regulatory Affairs Director

2 weeks ago

Far Hills, United States Proxima Full time

Are you a seasoned Regulatory Affairs professional with a passion for ensuring compliance and driving regulatory strategy in the medical device industry?

We're are on the look out for a dynamic Regulatory Affairs Director to lead regulatory initiatives for a one-of-a kind start-up in the Medical Device space.

As a key member of the team, you'll play a crucial role in bringing innovative medical devices to market while ensuring regulatory compliance.

**Key Responsibilities**:

- Develop and implement regulatory strategies to support product development, registration, and commercialization of medical devices in global markets.
- Provide regulatory guidance and support to cross-functional teams throughout the product lifecycle, including R&D, quality assurance, clinical affairs, and marketing.
- Represent the company in interactions with regulatory agencies, notified bodies, and other stakeholders to ensure successful regulatory outcomes.

**Desired Skills and Qualifications**:

- Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or related field.
- Minimum of 7 years of experience in Class III products, with a strong understanding of FDA regulations and international regulatory requirements.
- Proven track record of successfully leading regulatory submissions and obtaining regulatory approvals for medical devices.
- Excellent knowledge of regulatory pathways, including 510(k), PMA, IDE, and international registrations.
- Ability to thrive in a fast-paced, dynamic environment and collaborate effectively with cross-functional teams.

Join us in advancing healthcare innovation and bringing life-changing medical devices to patients worldwide.

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