Sr Regulatory Affairs Spec

We anticipate the application window for this opening will close on - 20 Nov 2025

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 is responsible for planning and executing global regulatory activities that are necessary in obtaining and / or maintaining regulatory clearance / certification within the United States and Europe for powered surgical devices. This position is largely responsible for sustaining activities and ad prom review. Sustaining activities include but are not limited to review of all change control activities related to assigned product family and performing regulatory assessments. Additionally this role will be responsible for the LTF 510(k)s technical documentation updates and EU change notices that result from the regulatory assessment. This role is also responsible for labeling and ad prom review of assigned product family. This role partners with the international regulatory affairs group to support global submissions and registrations.

Our Surgical OU is one new powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. Well approach the market with a unified approach from concept single strategy capitalize on our global commercial capabilities and prove the power of our combined portfolio.

With the Medtronic Mission as our North Star we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of Medtronic and the customers and patients we serve.

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

Support currently marketed products by completing sustaining activities which include but are not limited to evaluating product changes and labeling changes reviewing ad promo and submitting change notifications to regulatory authorities.

Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for changes to existing products. Work with RAS engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

Prepare FDA submissions and European Technical Files / Technical Documentation (MDD and MDR) for product changes and / or new products as required to ensure timely product launch.

Prepare submissions and reports for FDA and notified bodies and support other international agencies as required. May interact directly with FDA and notified bodies and indirectly with international regulatory agencies. All significant issues will be reviewed with the manager.

Maintain proficiency in US and EU regulatory requirements. Establish and maintain good relationships with agency personnel.

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.

Support post-market regulatory compliance activities for US and EU.

Keeps abreast of regulatory procedures and changes.

Develop and maintain regulatory affairs department procedures and implement process improvements.

Comply with applicable US EU and international regulatory laws / regulations / standards and the Code of Conduct

Assist in keeping the company informed of US and EU regulatory requirements.

Directs or performs coordination and preparation of document packages for internal audits and inspections.

Leads or compiles all materials required for submissions license renewals and annual registrations.

Direct or performs coordination and preparation of document packages for regulatory submissions from all areas of the company internal audits and inspections.

Leads or compiles all materials required in submissions license renewal and annual registrations.

Recommend 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.

Recommend strategies for earliest possible approvals of clinical trials applications.

Must Have : Minimum Requirements

Bachelors degree required

Minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years of relevant experience

Nice to Have

4 years of U.S. and EU regulatory submission experience (510(k) and Technical Documentation)

Experience with software and electrical regulatory requirements.

Experience with international standards (ISO GHTF ICH IEC).

Proficient understanding of FDA and MDR requirements.

Knowledge of Medical Device Quality Systems (21 CFR 820 ISO 13483)

Experience working with cross-functional teams.

Project management skills.

Product development experience.

Knowledge of Medtronic procedures and systems.

Knowledge of the business goals products therapy customer needs reimbursement and competitive environment.

Strong oral and written communication skills.

Effective interpersonal skills.

Effective team member.

Ability to comprehend principles of engineering physiology and medical device use.

Good analytical skills.

Ability to effectively manage multiple projects and priorities.

Proficient skills with MS Word MS Outlook MS Excel MS PowerPoint.

Experience with 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.

Salary ranges for U.S (excl. PR) locations (USD) : $92000.00 - $138000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The 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 and Simple 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) and Capital 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.

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.

Required Experience :

Senior IC

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 92000 - 138000