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 SeniorRegulatory Affairs Specialist will support our innovative Transcatheter Tricuspid Valve Therapy to treat tricuspid valve disease. This role is responsible for developing strategies for worldwide governmental approval to introduce new products (Class II and Class III) to market provides advice on regulatory requirements prepares worldwide submissions and negotiates their approval with the agencies. The Sr Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.

This position will support worldwide regulatory activities associated with the innovative transcatheter tricuspid valve therapy to treat tricuspid valve disease. This position will provide an opportunity to work on a new product development project for a Class III device that seeks to address an unmet need for patients.

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. We are working onsite 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Role and Responsibilities

• Team with operating unit Regulatory Affairs Specialists and international regulatory staff to develop and execute regulatory strategies for new and existing products ensuring alignment with business objectives and regulatory requirements.
• Collaborate with R&D Quality Clinical and Marketing teams to ensure regulatory compliance throughout the product development process and to resolve potential regulatory issues and questions from regulatory agencies.
• Prepare regulatory documentation for new products product changes audits as required to ensure timely approvals and compliance for clinical studies and market release. Review significant product submissions with manager and negotiate submission issues with agency personnel.
• Assist in negotiations with FDA and/or international regulatory agencies on assigned projects/products.
• Support regulatory compliance activities including manufacturing site registration audits annual reporting as needed.
• Monitor and analyze regulatory trends and changes providing strategic guidance to cross-functional teams.
• Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.
• Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.
• Maintain regulatory documentation to ensure compliance.
• Manage multiple projects prioritize daily tasks and ensure project deadlines are met.
• Contribute to continuous improvement and process optimization initiatives within the department.

Must Have: Minimum Requirements

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

• Bachelors degree required with a
• Minimum of 4years of experience in medical device regulatory affairs experience
• Or Advanced degree with2years of experience

Nice To Have

• Advanced degree in a scientific discipline (engineering physical/biological or health sciences)
• Experience with heart valve products
• Experience with Software as a Medical Device
• RAC Medical Device Certification
• Experience with Class II/III (510(k) PMA IDE) and EU MDR medical device submissions
• Experience with assessment and reporting of product changes according to US and EU regulatory requirements
• Product development experience
• Clinical or statistical experience
• Experience with FDA and international regulatory agency requirements ISO/GHTF standards
• Ability to comprehend principles of engineering physiology and medical device use
• Excellent communication negotiation and problem-solving skills.
• Effective interpersonal skills and team member
• Ability to effectively manage multiple projects and priorities in a fast-paced environment
• Detail oriented
• Proficient computer skills

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.