Senior Regulatory Affairs Spec
Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Medtronic
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
Our Purpose
This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results through providing guidance and mentorship to team members, supporting their development and helping them navigate complex regulatory requirements.
Collaborate closely with cross-functional partners such as R&D, clinical, operations, and marketing to ensure regulatory needs are integrated into product development and lifecycle management. Occasionally represent the company in discussions with regulatory bodies and industry groups, supporting regulatory compliance and business objectives supporting Acute Care & Monitoring achieve regulatory success and maintain a competitive edge.
Come for a job, stay for a career!
A Day in The Life:
The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Microstream™ Capnography Monitoring product portfolio within the Acute Care and Monitoring operation unit. Activities include participation in change development projects, review and approve design control documentation, regulatory change assessments, author regulatory documents (MDR Technical Documents, STEDs or 510ks) and supporting EU MDR implementation.
The Sr. RAS role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices.
Responsibilities may include the following and other duties may be assigned:
Directs or performs coordination and preparation of document packages for regulatory submissions.
Supports change control activities to support global approval and implementation of product and process changes.
Leads or compiles all materials required in CE-Mark and FDA submissions, license renewal and annual registrations.
Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
May have direct interaction with regulatory agencies on defined matters.
Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.
Key Skills & Experience
Level 8 Honor’s Degree Science or Engineering bachelor's degree/master's with a minimum of 5 years of relevant experience, preferably with Class III Medical Devices. A Regulatory Affairs qualification is desirable, but not mandatory.
Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required.
You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
You have strong technical knowledge. You are skilled in thinking critically and making sound decisions. Ability to comprehend principles of engineering, physiology, and medical device use.
You collaborate with global cross functional teams and create alignment with team members.
Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements.
Experience with software and hardware medical devices.
May provide guidance, coaching and training to other employees within job area.
You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behavior.
Ability to effectively manage multiple projects and priorities.
Has an excellent attention to detail and are results oriented.
Proven problem-solving skills with the ability to identify risks and escalate issues as appropriate.
Good initiative and team player.
Medtronic offer a competitive salary and flexible Benefits Package
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
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.
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.
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.
Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 61,440.00 EUR - 92,160.00 EUR | This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
U.S. Candidates
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 95,000+ 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
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.