Regulatory Affairs Specialist Jobs

Regulatory Affairs Specialist - Surgical

The Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within International Regions. The Regulatory Affairs Specialist will provide support for regulatory activities including technical writing to support regulatory submissions, product labeling, and instructions for use creation.

Operating Unit

Our Surgical OU is one new, powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. We'll approach the market with a unified approach from concept single strategy, capitalize on our global commercial capabilities, and prove the power of our combined portfolio.

With the Medtronic Mission as our North Star, we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of Medtronic and the customers and patients we serve.

Careers that Change Lives

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

To learn more about Inclusion & Diversity at Medtronic Click Here

Location: Remote within the U.S.

A Day in the Life

• Support preparation of International submissions.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Additional tasks as assigned
• Host international meetings as needed including monthly meetings to support assigned region.
• Participate on product development teams and/or operations change control teams, providing regulatory global strategy, timelines, and direction.
• Monitors and improves tracking / control systems.
• Host meetings with relevant R&D, Quality, Manufacturing facility, Marketing and Cross Functional Teams as needed to support global registration requirements.
• Review sustaining product changes, communicate to regions and assess impact of product changes per International regulatory strategy and submissions per standard procedures.
• Assist in keeping company informed of regulatory requirements in the International Regions.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Keeps abreast of regulatory procedures and changes.
• Help with development of International regulatory strategies for product submissions.
• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company.
• May direct interaction with regulatory agencies on defined matters.

• Bachelor's degree with 2 years of regulatory affairs experience

OR

• An advanced degree with 0 years of regulatory affairs experience

• Excellent communication skills
• Experience with international submissions and experience with the FDA
• Technical writing experience including authoring regulatory documentation, SOPs, product manuals, Instructions for Use (IFUs), process flows and work instructions.
• 3+ years of medical device regulatory affairs experience

Compensation