We anticipate the application window for this opening will close on - 9 May 2025
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 Senior Principal Regulatory Affairs Specialist will play a key role in creating regulatory strategies and submissions to bring new robotic products to the global markets. This role will also work on expanding indications of existing products, as well as work on sustaining/post-market regulatory activities for Class II robotic devices. Devices that are part of the Robotics Surgical Technology Business are inclusive of hardware and software components. The senior principal specialist will work directly with new product development and sustaining teams to develop the global regulatory strategy and support regulatory activities throughout the product lifecycle. The senior principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for Class II medical devices. This includes support of product changes to ensure that regulatory requirements continue to be met, documenting regulatory decisions, submissions to agencies, reviewing promotional materials, and ensuring that product technical documentation is current and accurate. Responsibilities are performed through the collaboration with various functions across the business unit, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, and Marketing.
Responsibilities also include keeping senior management informed of the regulatory status of products and significant regulatory issues and maintaining proficiency in global regulatory requirements.
The successful candidate will be able to deal with advanced concepts and undefined paths, work independently, develop new and creative regulatory strategies and work collaboratively within the Regulatory department and other business functions. This position reports to the Regulatory Affairs Director.
Location: Strong preference to have a candidate work hybrid from Boston, MA / North Haven, CT / or Lafayette, CO. We can also consider candidates to work hybrid from another MDT site within the U.S.
Travel: Less than 15%
A Day in the Life / Responsibilities:
• Develop and support global regulatory strategies for Class I, and II devices and accessories for robotic surgical application.
• Be an active member of the product development core teams and responsible for identifying submission deliverables, timelines, and strategic direction. Reviews and approves technical documentation.
• Provide feedback and work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies and provide ongoing support to product development teams to assure timely resolution to regulatory issues and questions.
• Prepare FDA IDE submissions, DeNovo/510(k) submissions, or EU submissions for new products and product changes as required.
• Directly communicates with regulatory authorities to resolve questions/issues that arise prior to and during product submissions or other pertinent issues.
• Participate in the product change assessments and define the regulatory impact of product changes in global markets.
Responsibilities may include the following and other duties may be assigned.
- 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.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS
Autonomy: Recognized master in professional discipline.
Works independently to implement strategic goals and establish operational plans for job area.
Assignments are often self-initiated Determines and pursues courses of action necessary to obtain desired results.
Organizational Impact: Strongly influences the design of new products, processes, standards, or operational plans based on business strategy with a significant impact on functional results .
Implements strategic goals established by functional leadership.
Changes or may establish operational plans for job area with long-range impact on results.
Innovation and Complexity: Faces problems that span a wide range of difficulty and unique issues across functions and / or businesses which may cause redirection .
Develops solutions to unique issues Improves upon existing processes and systems using significant conceptualizing, reasoning and interpretation .
Communication and Influence: Interacts with internal and external customers and vendors at various levels, including executive leadership, on significant matters.
Conducts briefings with senior leaders within the job function.
Negotiates with others to reach understanding or agreement.
Leadership and Talent Management: Frequently provides guidance, coaching and training to other employees .
Typically manages large, moderately complex initiatives of strategic importance to the organization, involving large cross-functional teams.
Required Knowledge and Experience: Requires mastery level knowledge of specialty area and working knowledge of several other areas, typically obtained through advanced education combined with experience.
May have deep knowledge of project management.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant 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):156,800.00 - 196,000.00 - 235,200.00 USDThe 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).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance,Health Savings Account,Healthcare Flexible Spending Account,Life insurance, Long-term disability leave,Dependent daycare spending account,Tuition 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 match,Short-term disability,Paid time off,Paid holidays,Employee Stock Purchase Plan,Employee Assistance Program,Non-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 95,000+ 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.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
