Regulatory Affairs Professional

2 weeks ago


Chanhassen, Minnesota, United States PMT Corporation Full time
PMT Corporation is a leading manufacturer and distributor of high-end, innovative products in the Orthopedic, Neurosurgery, and Plastic Surgery markets. We are seeking a highly organized and detail-oriented Regulatory Affairs Specialist to join our Quality and Regulatory department.

**Key Responsibilities:**

* Assess regulatory requirements and develop procedures for maintaining compliance with FDA/MDSAP, ISO, and MDD/MDR regulations
* Collaborate with Engineering and Quality Departments to ensure compliance throughout design and manufacturing processes
* Review Engineering Change Orders (ECOs) related to design, engineering, or manufacturing
* Work with Internal Auditors and Quality Managers on compliance-related matters
* Maintain positive relationships with External Auditors and Regulatory Agencies
* Interact with Regulatory Departments for International Distributors to assist in registrations and license renewals

**Requirements:**

* Bachelor's degree in Science, Regulatory Affairs, Engineering, or related field
* Minimum 2 years of experience in Regulatory Affairs in Health Sciences, preferably Medical Devices
* Regulatory Submission experience with 510Ks, notified bodies, or international MOH agencies
* Knowledge of regulatory processes for U.S. and EU, experience in other countries highly preferred
* Highly proficient attention to detail and extremely organized
* Strong work ethic and ability to consistently exceed expectations
* Excellent communication and time management skills
* Proficient in Microsoft Office Suite and Adobe
* Ability to work individually and in a team setting to accomplish goals and deadlines

**About PMT Corporation:**

PMT Corporation is a community of innovators who are passionate about creating an impact. We recognize that the collective power of our team is what propels us forward. Together, we celebrate successes, learn from challenges, and continuously evolve in our pursuit of excellence.

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