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

The Senior Regulatory Affairs Specialist will support Research and Development programs with pre-market regulatory strategy development for worldwide product registration with global regulatory agencies to introduce Coronary & Renal Denervation devices to market provides advice on regulatory requirements prepares worldwide submissions and negotiates their approval. This will include expertise in regulatory software development strategies (SaMD AI Machine Learning Cybersecurity etc.) to support the operating units (OUs) innovative pipeline. The specialist will work in collaboration with Regulatory Affairs Team members cross functional members at varying levels within the organization as well as International Regulatory Affairs staff supporting US and international submissions change management assessments the review and approval of advertising and promotional materials for commercial products across the CRDN portfolio and QMS audits as needed.

Role and Responsibilities:

• Act as a team member on development projects to provide regulatory guidance and develop global regulatory strategies and timelines for key markets.
• Author and prepare regulatory submissions for new products and their product changes as required to ensure timely approval for market release. Review significant regulatory issues with manager as necessary and resolve submission issues with Medtronic cross functional partners Medtronic Geography Regulatory partners and regulatory agencies as needed.
• Prepare regulatory strategies/plans taking inputs and incorporating worldwide compliance requirements. Provide on-going support to product development teams for regulatory issues and questions. Find interpret and apply regulations and guidance appropriately for situations.
• Provide business and product information to enable development of strategies and requirements as well as communicate that information to the product development teams.
• Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.
• Complete understanding and wide application of technical or regulatory principles theories and concepts. General knowledge of other related disciplines.
• Negotiate with regulatory agencies as needed.
• Participate in the project team meeting to plan strategies including reviewing the various specifications and plans/reports defining target market and distribution method Medtronic requirements on testing etc.
• Work under general supervision following established procedures. Independently determines and develops approach.
• Keep current on global directives regulations harmonized standards and Medtronic procedures and communicate changes that may affect cross functional areas.
• Provide mentorship training and support to other junior members of the department.
• Provide regulatory review and guidance for proposed product claims/labeling and advertising and promotional materials.
• Participate in inspections/audits either performed internally by notified bodies or by other international regulatory bodies.
• Assist regulatory department in the update enhancement and creation of internal policies and procedures.
• Support assessment and recommendation of new and changing regulations guidance documents requirements as needed
• Other tasks as required.

Must Have

To be considered for this role please ensure the minimum requirements are evident in your applicant profile

• Bachelors degree in a technical discipline
• 4 years of medical device regulatory experience OR 2 years of medical device regulatory experience with an advanced degree

Nice To Have

• Experience working in regulated environment including involvement with regulatory submissions interactions with regulatory agencies (e.g. FDA Notified Bodies NMPA and PMDA etc.) and working with cross-functional project teams
• Master of Science Degree
• In depth experience with FDA requirements guidance documents Medical Device Regulation ISO 14971 ISO 13485 and other global regulatory requirements and quality standards
• Experience working with cross functional PDP teams
• Direct Regulatory Affairs experience supporting programs throughout software development life cycle
• Direct experience authoring and successful approval of regulatory submissions for Class IIb /III/IV medical devices in the US Japan or EU (e.g. IDE PMA CTN Shonin Technical Documentation)
• Direct experience supporting successful software device development (SaMD AI Cybersecurity IEC 62304/82304) and associated regulatory filings in the U.S. EU and globally
• Experience with negotiations/interactions with regulatory agencies/health authorities
• Experience performing advertising and promotion reviews/approvals for medical devices
• Computer skills: MS Office MS Project Adobe Acrobat and Agile

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.

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.