Sr Specialist Regulatory Affairs - St Paul, MN

We are seeking a Regulatory Affairs Consultant for a 6-month contract-to-hire opportunity supporting Class II medical devices, with a strong focus on SaMD. · ...

Regulatory Affairs Specialist is responsible for ensuring compliance with regulatory requirements and supporting product registrations. The role involves preparing and submitting regulatory documentation, maintaining databases and document repositories, and providing guidance to ...

We are seeking a Regulatory Affairs Consultant for a 6-month contract-to-hire opportunity supporting Class II medical devices, · Lead and support preparation and filing of FDA 510(k) submissionsManage FDA communications related to submissions and regulatory strategySupport regula ...

The Regulatory Affairs Intern will assist the team by researching and reviewing clinical information pertaining to Scanlan medical devices and maintaining the relevant technical documentation in accordance with regulations.  They will be involved with essential activities require ...

The Regulatory Affairs Intern will assist the team by researching and reviewing clinical information pertaining to Scanlan medical devices. · Assist in post-market surveillance systemAssist in updating Technical Files and Risk File based on Post-Market Surveillance · ...

The Regulatory Affairs Intern will assist the team by researching and reviewing clinical information pertaining to medical devices and maintaining the relevant technical documentation in accordance with regulations. · ...

Join us as a Global Labeling Operations Manager , where you'll work alongside a large, dedicated client team to drive impactful labeling operations across global markets. · ...

Join us as a Global Labeling Operations Manager where you'll work alongside a large dedicated client team to drive impactful labeling operations across global markets oversee end-to-end labeling operations across multiple markets ensuring compliance with global regulatory require ...

We are seeking a Regulatory Affairs Lead to join our team. The ideal candidate will have strong analytical skills, excellent communication abilities, and a proactive approach. · ,Bachelor's Degree in a scientific discipline such as Chemistry or Chemical Engineering. · Minimum of ...

+Our client, a leading organization in the medical device and pharmaceutical industry, is seeking a Regulatory Affairs Lead to join their team. As a Regulatory Affairs Lead, you will be part of the Laboratory / Technical Family supporting regulatory and environmental compliance i ...

Under limited supervision, the Senior Regulatory Specialist is responsible for planning and executing critical and complex global regulatory projects necessary to obtain and maintain global regulatory approvals. · B.A. or B.S. degree in life science field (biology, microbiology, ...

We are seeking a detail-oriented Regulatory Affairs Specialist to support compliance quality management and regulatory activities within the sterile processing medical device division This role ensures adherence to international regulations standards supports product registration ...

About Nyxoah: · Nyxoah is a medical technology company focused on improving the lives of people with obstructive sleep apnea (OSA) through the development and commercialization of the Genio system. We operate in a dynamic, high-growth, highly regulated environment with teams acro ...

We are seeking a highly experienced Senior Regulatory Affairs Lead with 7–10 years of medical device regulatory experience to oversee a small team and drive critical international registration renewals. · Serve as the single point of contact for client stakeholders, · Lead, coord ...

About Nyxoah: · Nyxoah is a medical technology company focused on improving the lives of people with obstructive sleep apnea (OSA) through the development and commercialization of the Genio system. We operate in a dynamic, high-growth, highly regulated environment with teams acro ...

We anticipate the application window for this opening will close on - · 16 Feb 2026 · A Regulatory Affairs Specialist helps develop strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and ...

+Job summary · Join Thermo Fisher Scientific as a Regulatory Affairs Specialist III and contribute to ensuring compliance with global regulations while enabling our mission to make the world healthier, cleaner, and safer. · +Bachelor's degree or higher in a science or engineering ...

We anticipate the application window for this opening will close on February 16th,2026.At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. · ...

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all A Day in the Life REGULATORY AFFAIRS SPECIALIST · Onsite · The Regulatory Affairs Specialist develops strategies for worldwide product registrat ...

We're hiring a Senior Regulatory Affairs Specialist to support global medical device compliance across the U.S., Canada, and Europe. · Maintain and update European technical documentation, · Prepare and manage annual regulatory registrations for the U.S. (FDA), Canada, and other ...