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 intent behind the design of the Global Operations and Supply Chain (GO&SC) strategy is to create a more agile and responsive manufacturing and supply chain organization. One that anticipates and meets the needs of our customers, our patients, and our stockholders – effectively becoming a competitive advantage for Medtronic. One of the ways we do this is by leveraging dedicated teams to enable efficient execution of our post-market changes.

In this exciting role as a Senior Regulatory Affair Specialist, you will have responsibility for planning and executing regulatory strategy for molding and capital tooling projects, assessing the regulatory impact of post-marketing changes, as well as, leading project teams through the regulatory requirements. The position will report into the Medtronic Surgical Regulatory organization.

Location: This job opening is targeting a hybrid work model with on-site work in either Mansfield, MA, North Haven, CT or Lafayette, CO. We will consider candidates to work remotely from the U.S., but have a strong preference for on-site talent.

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

• RA representative on project teams.
• Planning and executing regulatory strategy for molding & capital tooling projects.
• Performing regulatory assessment for post-market changes.
• Creates/manages all materials required to support project deliverables.
• Monitors and remains in compliance with multiple Quality Management Systems.
• 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.​

Required Knowledge and Experience:

• Bachelor’s degree with 4+ years of experience in regulatory affairs

OR

• Advanced degree with 2+ years of experience in regulatory affairs

Nice to Have:

• 4+ years of experience in medical device regulatory affairs.
• US and global regulatory affairs knowledge and submission experience.
• Advanced degree in engineering or regulatory affairs.
• Microsoft Word, Excel and Adobe software skills.
• Experience working with cross-functional teams.
• Experience working with technical documentation/STED.
• Effective verbal and written communication skills both internally and externally.
• Experience with solving problems and concerns.
• Experience with project management and adherence to time schedules.
• Works well under pressure in a dynamic environment.
• Highly organized, detail-oriented, and efficient.
• Team player who seeks to help and learn from colleagues seeing the department's success as their own
• Ability to manage projects to completion within and outside of the direct department and company.
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism.
• Proactively seeks to develop and become well-versed within the regulatory landscape.
• RAPS Regulatory Affairs Certification (RAC).
• Previous Medtronic experience

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):$88,800.00 - $133,200.00

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.