Job Information
Actalent Regulatory Affairs Specialist in Osseo, Minnesota
Job Title: Regulatory Affairs Specialist
Job Description
In this role, the Senior Regulatory Specialist will lead the creation of EU MDR technical files, review product development materials, and create regulatory submissions for the active implantable medical devices for the Neuromodulation Business Unit. The Specialist will work as a liaison with various teams in the organization, effectively communicating and collaborating on deliverables to meet project deadlines in line with regulatory requirements. Duties include authoring, preparing and updating Technical Files in accordance with requirements, serving as a core-team regulatory member for new product development, and handling regulatory authority queries on Technical files or submissions. The Specialist will also maintain a continued awareness and understanding of EU and FDA regulations and guidance documents, prepare regulatory submissions, and directly interface with the International Regulatory Agencies on assigned projects.
Hard Skills
+8 Years of Regulatory Affairs
+5 Years of Medical Device
+3 Years of New Product Regulatory Support (PMA)
Soft Skills
Effective communication
Collaboration
Awareness of EU and FDA regulations and guidance documents
Job Type
This is a contract position with a duration of 24 Month(s).
Work Site
This is a fully remote position.
Work Environment
This position requires a high level of collaboration with various teams within the organization. The Specialist will directly interface with International Regulatory Agencies on assigned projects, and should be capable of handling multiple projects simultaneously while meeting tight deadlines.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.