Regulatory Affairs Specialist

Medtronic•Mounds View, MN

2d•$74,400 - $111,600•Onsite

About The Position

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.

Requirements

Bachelor’s degree required
Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
U.S. work authorization is required for roles below Principal level.

Nice To Haves

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.

Responsibilities

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.