Regulatory Affairs Specialist

Regulatory Affairs Specialist

Medtronic is seeking a Regulatory Affairs Specialist to support the Wound Management Regulatory Affairs team. The selected candidate will provide regulatory support on a range of medical devices focusing on a diverse line of Sutures (absorbable/non-absorbable, coated/uncoated). Regulatory support will focus on sustaining globalization, international submissions, commercial support, manufacturing support, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Wound Management business.

Responsibilities may include the following and other duties may be assigned:

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.

To be considered for this role, you must have:

• Bachelor's degree required
• Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience.

Preferred qualifications include:

• Experience with U.S. FDA and international regulatory requirements for medical devices
• Familiarity with EU MDR, MDD, ISO 13485, ISO 14971, and related standards
• Experience supporting regulatory submissions, audits, or inspections
• Strong written and verbal communication skills
• Strong organizational skills with the ability to manage multiple priorities
• Experience collaborating in a cross-functional, fast-paced environment
• Familiarity with medical device product development or lifecycle management
• RAC certification or progress toward certification
• Experience working with Notified Bodies or global regulatory agencies.

Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.