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

A Day in the Life

Across our global Neuroscience organization we advance care for some of medicines most complex neurological and spinal conditions. By combining innovative technology data-driven insights and deep clinical expertise we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey.

Our Neuromodulation Operating Unit provides advanced therapies for chronic pain movement disorders and other neurological conditions. Through spinal cord stimulation deep brain stimulation and targeted drug delivery systems we deliver personalized treatments that restore function reduce symptoms and improve quality of life worldwide.

Check us out on LinkedIn: Medtronic Brain Modulation and Pain Interventions

The PrincipalRegulatory Affairs Specialist(Pr. RAS) is responsible for developing Class II and Class III medical device regulatory strategies and preparing US and worldwide product submissions to introduce products and changes to the market. The Pr. RAS also supports marketed product activities including the development of advertising and promotional materials license maintenance annual reports renewals design/manufacturing change notifications QMS audits and manufacturing site registrations.

At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Overview of Role

• Ability to travel periodically to a design site in the US for in-person collaboration with development teams.
• Prepare and support US EU and Canadian submissions and reviews and support international submission reviews for new products and product changes to ensure timely market release approvals. Interact directly with FDA and/or indirectly with international regulatory agencies on most projects at the reviewer level and resolve submission issues with internal cross-functional team members Medtronic geography regulatory partners and regulatory agencies as needed.
• Lead and execute regulatory strategies/plans and provide regulatory compliance requirements in support of cross-functional product development and product change teams.
• Find interpret and apply regulations and guidance appropriately for situations.
• Provide regulatory support for currently marketed includes reviewing changes to existing devices labeling and other submissions and reports for regulatory agencies as required.
• Collaborate with Marketing and Medical Education teams to develop and maintain advertising promotion and educational materials.
• Support regulatory compliance activities including manufacturing site registration audits post-market vigilance reporting product recalls etc. as needed.
• Review significant regulatory issues with supervisor as necessary and work under general supervision following established procedures. Independently develop and determine a regulatory approach.
• Keep current on global directives harmonized standards and procedures and communicate changes that may affect cross-functional areas.
• Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure compliance with the quality system and high-quality work.
• Provide training and support for other members of the department. May mentor or supervise other RAS as directed by the manager.
• Other tasks as required.

Must Have: Minimum Requirements

• Bachelors degree in life science engineering or a related field
• Minimum 7 years of relevant experience or an advanced degree with 5 years of experience

Nice To Have

• 7-10 years of industry experience with at least 4-5 years in regulatory clinical or quality roles.
• Advanced degree in a scientific discipline (engineering physical/biological or health sciences)
• Experience working in a regulated biotechnology environment including involvement with regulatory submissions interactions with regulatory agencies (e.g. FDA EU Notified Body) and working with cross-functional project teams.
• In-depth experience with FDA requirements guidance documents Active Implantable Medical Device Directive (AIMDD)/EU Medical Device Regulation (MDR) ISO 14971 ISO 13485 and other global regulatory requirements and quality standards
• Experience with Class II medical devices (510(k))
• Experience with Class III medical devices (PMA)
• History of successful device submissions
• Strong negotiation skills and written/oral communication skills
• Strong organizational and time management skills
• Ability to multitask support multiple projects function on a global basis prioritize conduct team meetings and meet project deadlines
• Ability to work independently and under general direction only
• Computer skills: MS Office MS Project Adobe Acrobat and Agile

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.

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.

U.S. Work Authorization & Sponsorship

At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Join us in our mission to alleviate pain restore health and extend lifewhere your unique background and perspective are valued.

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.

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

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 95000 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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.