PMT Corporation
Regulatory Affairs Specialist
PMT Corporation, Chanhassen, Minnesota, United States, 55317
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PMT Corporation, located in Chanhassen, Minnesota, is known for manufacturing and distributing high end, innovative products within the Orthopedic, Neurosurgery, and Plastic Surgery markets. Our workplace 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.
Join us at PMT Corporation if you're ready to be a part of a collaborative, idea-driven, and communicative environment. Your innovation matters, and together, we can continue to shape the future of the medical device industry.
REGULATORY AFFAIRS SPECIALIST OVERVIEW:
The Quality and Regulatory department supports the registration and compliance of PMT Corporation's products in the U.S. and for over 100 distributors worldwide. The Regulatory Affairs Specialist will focus on assisting with maintaining product compliance with FDA/MDSAP, ISO, and MDD/MDR requirements. We are looking for an excellent communicator and highly organized individual to join our team on-site with an 8:00am - 4:30 pm shift time.
DUTIES AND RESPONSIBILITIES OF THE REGULATORY AFFAIRS SPECIALIST:Assess regulatory requirements as well as develop procedures and strategies for maintaining compliance.Maintenance of FDA/MDSAP, ISO, and MDD/MDR complianceWork with Engineering and Quality Departments in product development to ensure compliance throughout design and manufacturing processesReview Engineering Change Orders (ECOs) relating to design, engineering, or manufacturingWork directly with Internal Auditors and Quality Managers on compliance related mattersMaintain positive relationships and interact directly with External Auditors and Regulatory Agencies at the reviewer levelInteract with Regulatory Departments for International Distributors to assist in registrations and license and certificate renewalsProvide support and leadership on development projects and regulatory issues to ensure timely submissions for market clearancePrepare U.S. and International submissions for new products or product changes in a timely mannerOther duties as assignedQUALIFICATIONS OF THE REGULATORY AFFAIRS SPECIALIST:
Bachelor's degree in Science, Regulatory Affairs, Engineering, or other related fieldMinimum 2 years of experience in Regulatory Affairs in Health Sciences, preferably Medical DevicesRegulatory Submission experience with 510Ks, notified bodies, or international MOH agenciesKnowledge of regulatory process for U.S. and EU, experience in other countries highly preferredHighly proficient attention to detail and extremely organizedStrong work ethic and able to consistently exceed expectationsExcellent communication and time management skillsProficient in Microsoft Office Suite and AdobeAble to work individually and in a team setting to accomplish goals and deadlinesAble to pass a pre-employment Background and Drug Screening
PMT is an Equal Opportunity Employment
Location: Chanhassen, MN
JOB CODE: RASDec2023
PMT Corporation, located in Chanhassen, Minnesota, is known for manufacturing and distributing high end, innovative products within the Orthopedic, Neurosurgery, and Plastic Surgery markets. Our workplace 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.
Join us at PMT Corporation if you're ready to be a part of a collaborative, idea-driven, and communicative environment. Your innovation matters, and together, we can continue to shape the future of the medical device industry.
REGULATORY AFFAIRS SPECIALIST OVERVIEW:
The Quality and Regulatory department supports the registration and compliance of PMT Corporation's products in the U.S. and for over 100 distributors worldwide. The Regulatory Affairs Specialist will focus on assisting with maintaining product compliance with FDA/MDSAP, ISO, and MDD/MDR requirements. We are looking for an excellent communicator and highly organized individual to join our team on-site with an 8:00am - 4:30 pm shift time.
DUTIES AND RESPONSIBILITIES OF THE REGULATORY AFFAIRS SPECIALIST:Assess regulatory requirements as well as develop procedures and strategies for maintaining compliance.Maintenance of FDA/MDSAP, ISO, and MDD/MDR complianceWork with Engineering and Quality Departments in product development to ensure compliance throughout design and manufacturing processesReview Engineering Change Orders (ECOs) relating to design, engineering, or manufacturingWork directly with Internal Auditors and Quality Managers on compliance related mattersMaintain positive relationships and interact directly with External Auditors and Regulatory Agencies at the reviewer levelInteract with Regulatory Departments for International Distributors to assist in registrations and license and certificate renewalsProvide support and leadership on development projects and regulatory issues to ensure timely submissions for market clearancePrepare U.S. and International submissions for new products or product changes in a timely mannerOther duties as assignedQUALIFICATIONS OF THE REGULATORY AFFAIRS SPECIALIST:
Bachelor's degree in Science, Regulatory Affairs, Engineering, or other related fieldMinimum 2 years of experience in Regulatory Affairs in Health Sciences, preferably Medical DevicesRegulatory Submission experience with 510Ks, notified bodies, or international MOH agenciesKnowledge of regulatory process for U.S. and EU, experience in other countries highly preferredHighly proficient attention to detail and extremely organizedStrong work ethic and able to consistently exceed expectationsExcellent communication and time management skillsProficient in Microsoft Office Suite and AdobeAble to work individually and in a team setting to accomplish goals and deadlinesAble to pass a pre-employment Background and Drug Screening
PMT is an Equal Opportunity Employment
Location: Chanhassen, MN
JOB CODE: RASDec2023