Sr. Specialist, Regulatory Affairs

Regulatory Affairs (RA) Intern The Regulatory Affairs team is responsible for executing regulatory strategies, submissions, interactions with regulatory authorities, and supports business by obtaining regulatory approvals for MicroVention TERUMO products. As a Regulatory Affairs Intern, you will learn the product development process through a regulatory...

12694BRTitle:Intern, Regulatory AffairsJob Description:Regulatory Affairs (RA) InternThe Regulatory Affairs team is responsible for executing regulatory strategies, submissions, interactions with regulatory authorities, and supports business by obtaining regulatory approvals for MicroVention TERUMO products.As a Regulatory Affairs Intern, you will learn the...

**About the Role**We are seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs team as an Intern. As a key member of our team, you will learn the product development process from a regulatory perspective and gain valuable experience in executing regulatory strategies.In this role, you will have the opportunity to develop...

Job DescriptionThis position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Job duties:Serves as a member on project teams completing tasks as assigned by the team.Aides in the execution of the regulatory...

Job DescriptionAssume worldwide responsibility, while working closely with the SVP, Global Quality & Regulatory Affairs, to map the optimal and contingent regulatory strategies to support product registrations, compliance with domestic and international regulations and marketing message. Obtain worldwide regulatory approvals. Assure compliance to domestic...

Provide guidance to inter-disciplinary project teams on regulatory requirements on projects at Phase 1 to 4 of drug development/life cycle. Compile and file high-quality CTD/eCTD submissions to regulatory authorities (e.g., briefing books, INDs and IND amendments, NDAs and NDA supplements, CTN/CTA, IMPDs, annual progress reports in different formats etc). ...

Job DescriptionResponsible for preparing strategy for worldwide product approval submission activities, responsible for submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. Job duties:Represent Regulatory on project teams and partner with...

INNOVATION STARTS WITH YOU Are you interested in working for an organization that is making a difference in people's lives every day? We're a medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We're a high-growth, customer-focused company with an entrepreneurial spirit producing some of the...

Job DescriptionINNOVATION STARTS WITH YOU Are you interested in working for an organization that is making a difference in people's lives every day? We're a medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We're a high-growth, customer-focused company with an entrepreneurial spirit...

Responsible for supporting and leading the management of Professional Affairs and Clinical Education initiatives and programs to maintain and expand the worldwide adoption of MicroVention products. Provide leadership with MVI programs including but not limited to; Proctoring Programs, Clinical Immersion Programs (CIPs), and Mentorship Programs from a...

Lead project teams in developing, finalizing, and implementing product labels, instructions for use, and patient implant cards. Ensure labels adhere to regional requirements and international standards along with cross-functional input from Marketing, R&D, Regulatory Affairs, and Legal. Job duties:Responsible for end-to-end labeling activities for multiple...

Job DescriptionLead project teams in developing, finalizing, and implementing product labels, instructions for use, and patient implant cards. Ensure labels adhere to regional requirements and international standards along with cross-functional input from Marketing, R&D, Regulatory Affairs, and Legal. Job duties:Responsible for end-to-end labeling activities...

Job Description Job Description Salary: $150-175kAbout SpyGlass Pharma:At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of...

Lead project teams in developing, finalizing, and implementing product labels, instructions for use, and patient implant cards. Ensure labels adhere to regional requirements and international standards along with cross-functional input from Marketing, R&D, Regulatory Affairs, and Legal. Job duties:Responsible for end-to-end labeling activities for multiple...

This 18-month rotational program is designed to train new Engineers on various aspects of MicroVention Terumo technology, procedures, and processes. All candidates will be assigned a Mentor, Peer Mentor, as well as an Advisor to oversee their program succession, and will be provided with additional classroom training. Successful candidates will have three...

This 18-month rotational program is designed to train new Engineers on various aspects of MicroVention Terumo technology, procedures, and processes. All candidates will be assigned a Mentor, Peer Mentor, as well as an Advisor to oversee their program succession, and will be provided with additional classroom training. Successful candidates will have three...

Job DescriptionManage individuals from entry-level to mid-level experience, develop and launch products, research new ideas, and manage overall design history. Focus is on both theoretical and practical solution development through the application of the scientific process and project management. Job duties:Manage a group of individuals of varying technical...

12584BRTitle:Sr. Engineer, Supplier QualityJob Description:Responsible for supporting programs that reduce overall costs and improve supplier performance. Organize and report key supplier performance metrics to the Quality organization and other departments. Perform supplier audits to evaluate quality systems, process, services, and supplier capabilities....

12583BRTitle:Engineer Sr, Quality Production SupportJob Description:Support the manufacture of medical devices. Work with Manufacturing and R&D Engineering teams to support manufacturing process changes, resolve product quality issues, and support the implementation of new products. Job duties:Work with Manufacturing Engineers on process improvement and cost...

Job DescriptionLead the organization's clinical science function and ensure the quality and integrity of all clinical data communicated internally and externally. Job duties:Drive the development and management of the clinical science organization via procedure implementation, training, and ensuring timely execution of deliverables. Provide hands-on...