Director of Compliance and Regulatory Strategy
4 weeks ago
Riverpoint Medical LLC is a leading provider of premium medical devices, and we are seeking an experienced Director of Compliance and Regulatory Strategy to join our team.
The estimated annual salary for this position is $145,000 - $185,000 depending on experience.
Job DescriptionIn this role, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulatory requirements. This includes monitoring regulatory changes, providing guidance to cross-functional teams, and overseeing internal audits.
You will also be responsible for:
- Developing and executing regulatory plans for new and existing medical devices.
- Providing regulatory expertise to cross-functional teams throughout the product lifecycle.
- Maintaining all necessary product documentation and technical records as required by regulations.
To be successful in this role, you will need:
- Bachelor's degree in a scientific, engineering, or healthcare-related field.
- Minimum of 7 years' experience in an ISO13485, FDA, and EU regulated environment.
- Experience in manufacturing or quality assurance in an FDA-regulated setting, with a thorough understanding of cGMP, QSR, MDR, and ISO13485 standards.
- Proven experience with FDA submissions (510(k), PMA) and international regulatory requirements (CE marking, EU MDR, etc.).
Riverpoint Medical LLC offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) with company match, paid time off, and 8 company-paid holidays. We are committed to a diverse and inclusive workplace and are an equal opportunity employer.
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