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

SENIOR REGULATORY AFFAIRS SPECIALIST

In collaboration with leading clinicians researchers and scientists worldwide Medtronic offers the broadest range of innovative medical technology. The company strives to provide products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

Saving lives is part of our everyday DNA. Real people with debilitating conditions can now be given back active lives through the restorative therapies that we provide. Therefore we are looking for a passionate Senior Regulatory Affairs Specialist who has direct experience submitting regulatory submissions for both the Americas and the EU.

Role Overview

The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to market. This role involves:

• Providing expert advice on regulatory requirements
• Preparing submissions
• Negotiating their approval
• Assisting with license maintenance including annual reports renewals design/manufacturing change notifications QMS audits and manufacturing site registrations

A Day In The Life

• Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products.
• Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
• Prepare FDA European and Canadian submissions for product changes to ensure timely approval for market release.
• Review significant regulatory issues with the manager as necessary and resolve submission issues with engineering partners geography regulatory partners and regulatory agencies as needed.
• Support regulatory compliance activities including manufacturing site registration audits post-market vigilance reporting and product recalls.
• Provide regulatory support for currently marketed products including reviewing labeling and changes to existing devices and documentation.
• Provide feedback and ongoing support to product development teams for regulatory issues and questions.
• Interact directly with FDA and international regulatory agencies on most projects/products at reviewer level with significant issues reviewed with the manager.

To Be Successful in This Role

• Medical Device Experience: Direct experience in the medical device industry particularly with Class III medical devices (PMA).
• 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 guidance documents EU MDR ISO 14971 ISO 13485 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 only.
• Computer Skills: Proficiency in MS Office MS Project Adobe Acrobat and Agile.

Must Have: Minimum Requirements

• Bachelors degree in a scientific discipline or equivalent with 4 years of relevant experience or an advanced degree with 2 years of experience.

Nice To Have

• 5-8 years of industry experience with at least 2-3 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 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.