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

This position is an exciting opportunity to work with Medtronics Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential enabling us to operate with greater speed and agility. As a separate entity we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

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

• Develop and refine least burdensome clinical regulatory strategies to support innovations in the Diabetes business with stakeholders across the businessUS EU international regulatory teams as well as from various partner functions such as reimbursement and R&D.

• Maintain proficiency of worldwide regulatory intelligence including competitor filings as part of developing innovative clinical regulatory strategies.

• Manage projects assigned to support business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products that require clinical evidence.

• Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

• Prepare FDA European and rest of world clinical submissions for next-generation diabetes products and product changes that require clinical evidence (i.e. IDEs and Competent Authority)

• Review significant regulatory issues with the manager as necessary and resolve submission issues with engineering partners geography regulatory partners and regulatory agencies as needed.

• Responsible for the preparation of the clinical portion of submission packages for commercialization (e.g. PMAs 510k Technical file dossiers international submissions etc.).

• Assisting with license maintenance including annual reports renewals design change notifications and QMS audits.

• Follow all work/quality procedures to ensure quality system compliance and high-quality work.

• Interact directly with FDA Notified Bodies and international regulatory agencies on most projects/products at the reviewer level with significant issues reviewed with the manager.

• Other duties as assigned.

• Position is 100% remote.

• Ability to travel up to 10% as business and local policies allow.

To Be Successful in This Role

• Medical Device Experience: Direct experience in the medical device industry particularly with Class III/II medical devices for both FDA and EU

• Regulatory Submission Expertise: Proven experience preparing and submitting regulatory filings to the FDA EU MDR and other global regulatory agencies.

• Knowledge of Regulatory Requirements: In-depth understanding of FDA requirements FDA and MDCG guidance documents EU MDR ISO 14971 ISO 13485 Good Clinical Practice ICH guidelines and other global regulatory requirements and quality standards.

• Strong Communication Skills: Excellent negotiation written and oral communication skills to effectively interact with regulatory agencies and cross-functional teams.

• Organizational Skills: Strong time management skills with the ability to multitask support multiple projects prioritize conduct team meetings and meet project deadlines.

• Independence and Initiative: Ability to work independently and under general direction.

• Computer Skills: Proficiency in MS Office MS Project and Adobe Acrobat.

Must Have: Minimum Requirements
To be considered for this role please ensure the minimum requirements are evident in your applicant profile.

Bachelors degree in a scientific healthcare or regulatory-related field and 4 years of regulatory affairs experience preferably with medical device submissions registrations or advertising and promotional review.

OR

Advanced Degree in a scientific healthcare or regulatory-related field and 2 years of regulatory affairs experience preferably with medical device submissions registrations or advertising and promotional review.

Nice to Have:

• 5-8 years of medical device industry experience with at least 2-3 years in regulatory and clinical roles.

• Advanced degree in a scientific discipline (engineering physical/biological or health sciences).

• Experience working in a regulated biotechnology environment including extensive involvement with regulatory submissions and interactions with regulatory agencies.

• History of successful device submissions.

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.