ASSOCIATE REGULATORY AFFAIRS SPECIALIST (Remote)

Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. This position will reside in the Peripheral Vascular Health organization. It includes Peripheral Stents, Directional Atherectomy devices, PTA and Drug Coated Balloons and cares for millions of patients globally with life-enhancing therapies.

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.

Careers That Change Lives

The Associate Regulatory Affairs Specialist working under the guidance of more senior regulatory specialists/manager will provide support for PVH products. Emphasis is on the post market sustaining activities which includes maintaining regulatory approvals, assessment of device changes for registration implications and support in geo expansions registrations.

A Day in The Life

• Contributes to global product registration maintenance, including EU MDR Technical Documentation/MDD Technical Files and Global Submission Summary Document.
• Participates in preparation for and during internal and external regulatory audits
• Compiles materials required for new global product submissions, license renewals and change submissions.
• Monitors and improves global regulatory tracking/control systems
• Request, obtain and maintain FDA CFGs including notarization and legalization, EC/ISO certificates and various other regulatory documents.
• Participate in investigative activities such as CAPA’s and non-conforming product
• Perform other regulatory affairs duties when requested

• Bachelor's degree required with 0 years of regulatory affairs or related experience
  

• Bachelors Degree in health profession, science and/or engineering field
• Demonstrated technical writing skills.
• Strong computer skills, including word processing, spreadsheets and slide presentations
• Excellent organizational skills
• Strong written, verbal and interpersonal skills
• Experience in medical device Industry