Regulatory Affairs Specialist at Medtronic in Plymouth, Minnesota

Job Description:

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life
The Regulatory Affairs Specialist (RAS) is responsible for collaborating, planning and executing regulatory activities related to modifications of the Lung Health product portfolio. Activities include support of regulatory assessments for United States (US) and European Union (EU) products, supporting EU MDR implementation, and supporting international submission requests. This position is most suited for individuals with working knowledge and experience of regulatory requirements for the total life cycle of medical devices. The initial project scope for this employee will be related to regulatory sustaining activities. New product development activities may be tied into the role later on.

Location: Strong preference to have candidates work hybrid from Plymouth, MN. Remote within the U.S. may be considered for the right candidate.
Responsibilities may include the following and other duties may be assigned.

• Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations


• Prepare 510(k) submissions and technical documents to support CE mark and other international submissions


• Support international product registrations as needed


• Manage multiple projects and prioritize tasks on day-by-day basis to meet project schedules


• Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities


• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards


• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements


• Participate in internal and external audits as needed


• Maintain Regulatory Affairs documentation to support compliance with applicable regulatory requirements


• Coordinate and prepare document packages for regulatory submissions from all areas of company, internal audits, and inspections


• 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.


• May direct interaction with regulatory agencies on defined matters.


• Keeps abreast of regulatory procedures and changes.

Required Knowledge and Experience:

• Bachelor's degree with 2+ years of experience in regulatory, legal, quality, biomedical engineering, clinical, medical, or vigilance.

OR

• An advanced degree with 0+ years of experience in regulatory, legal, quality, biomedical engineering, clinical, medical, or vigilance.

Nice to Have

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


• Interpersonal, analytical, technical writing, and organizational skills


• Prior experience working with Class II products (US) and Class I, IIa, and IIb products (EU)


• Experience authoring or assisting with regulatory submissions (e.g., 510(k), EU Design Dossier and/or Technical Documentation)


• Working knowledge of FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards


• Advertising and promotional material review experience


• Regulatory Affairs Certification (RAC) and/or Master's degree in Regulatory Affairs


• Systems Knowledge such as RA systems, Agile, SharePoint, or Quality Management Systems

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

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.

Salary ranges for U.S (excl. PR) locations (USD):$69,600.00 - $104,400.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here .

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

At Medtronic, most positions are posted on our career site for 3-7 days.