We anticipate the application window for this opening will close on - 22 Nov 2024

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 Program Manager will lead the strategic planning and execution of regulatory submissions and compliance initiatives within the Advanced Surgical Technologies product portfolio. This role will involve close collaboration with cross-functional teams, including R&D, Quality, Clinical, and Marketing, to drive regulatory submissions and maintain compliance throughout the product lifecycle. This position is most suited for individuals with extensive knowledge and experience of regulatory requirements for the total life cycle of medical devices, with a background in program and/or people management. 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 a candidate work hybrid from Plymouth, MN / North Haven, CT / Woburn, MA. Will consider candidates to work from another MDT facility in the U.S. or work remotely within the U.S for the right candidate.

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

• Develop and execute regulatory strategies for new and existing medical devices and products.
• Directs or performs coordination and preparation of document packages for regulatory submissions (510(k), IDE, EU Technical Documentation, international registrations, etc.), audits, and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Monitor and interpret regulatory requirements and guidance documents to ensure compliance.
• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements.
• Provide regulatory expertise and guidance to regulatory team and cross-functional teams during product development and commercialization.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Monitors and improves tracking / control systems.

Must Have: Minimum Requirements

• Bachelors degree with 5+ years of medical device regulatory affairs experience

OR

• An advanced degree with 3+ years of medical device regulatory affairs experience

Nice to Have:

• 6+ years of experience in medical device regulatory affairs with roles displaying added responsibility
• Experience with 510(k), IDE, DeNovo and/or PMA regulatory submissions for complex and connected systems (e.g. capital equipment, software, instruments and accessories or other devices of similar complexity) program management and implementation
• Experience working with US FDA, EU Notified Bodies and/or other regulators during the review of technical documentation
• Prior program or people management experience.
• Demonstrated ability for strategic thinking, project planning and project management
• Experience driving initiatives and change management
• Strong influence management skills. Demonstrated ability to work cooperatively at all levels in an organization to build and maintain relationships required to accomplish program goals
• Ability to balance priorities, work independently or collaboratively to determine and develop solutions
• Exceptional facilitation, analytical, planning, organization and time management skills to effectively execute project plans
• Excellent decision-making skills. Ability to negotiate and balance decisions and manage competing priorities across multiple functional areas
• Excellent verbal/ written communication and presentation skills. Demonstrated ability to succinctly and accurately communicate to various levels of management and across the organization

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):$114,400.00 - $171,600.00This 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.