Principal Regulatory Affairs Specialist - MiniMed

Medtronic plc; Greater London; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A global health technology company is seeking a Principal Regulatory Affairs Specialist in London. This hybrid role involves ensuring regulatory compliance for medical devices, including submissions to UK MHRA and CE/UKCA marking. The ideal candidate should have substantial experience in medical device regulations, excellent technical writing skills, and the ability to interact effectively with regulatory authorities. This position offers a competitive salary and a commitment to employee development.

Benefits

Competitive salary

Flexible benefits package

Short-term incentive plan

Qualifications

• Experience with UK MHRA submissions and CE/UKCA marking.
• Strong knowledge of ISO 13485 and ISO 14971 principles.
• Ability to interact effectively with regulatory authorities.

Responsibilities

• Coordinate document packages for regulatory submissions.
• Lead preparation of submissions and license renewals.
• Advise on compliance changes regarding labelling and protocols.

Skills

Experience in medical device regulatory

Knowledge of EU MDR

Technical writing skills

Job description

Principal Regulatory Affairs Specialist - MiniMed page is loaded## Principal Regulatory Affairs Specialist - MiniMedremote type: Hybridlocations: London, London, United Kingdomtime type: Full timeposted on: Posted Todayjob requisition id: R52703At 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**This position is an exciting opportunity to work with Medtronic's 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.Medtronic is hiring a Regulatory Affairs Specialist responsible for operating as an established, productive individual contributor who works independently on moderately complex projects with general supervision. In the position, you will set objectives for your own work to align with broader project goals and actively contribute to key milestones. You may also participate in cross-functional activities, requiring awareness of wider organizational issues even though the challenges you face are generally not highly complex.You will recommend improvements to systems and processes to enhance effectiveness and regularly communicate with internal stakeholders to share updates, gather input, and support decision-making. While your external interactions are limited and straightforward, you may guide entry-level professionals or support staff, eventually offering direction and assistance when needed.**Responsibilities may include the following and other duties may be assigned:*** Direct or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.* Lead and compile all materials required in submissions, license renewal and annual registrations.* Recommend changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.* Monitor and improve tracking as well as control systems.* Keep 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.**Required knowledge and experience*** Experience in medical device regulatory, including UK MHRA submissions and CE/UKCA marking* Strong knowledge of EU MDR, ISO 13485, and ISO 14971 risk management principles* Proven experience preparing regulatory dossiers, technical files, and product registrations* Ability to interact effectively with Notified Bodies and regulatory authorities, including supporting audits and FSCAs* Excellent technical writing skills with the ability to interpret and apply regulatory guidance**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.# **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.This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).# **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* **Build** a better future, amplifying your impact on the causes that matter to you and the world* **Grow** a career reflective of your passion and abilities* **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learningThese commitments set our team apart from the rest:**Experiences that put people first**. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.**Life-transforming technologies**. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.**Better outcomes for our world**. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.**Insight-driven care**. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in careIt 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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click .For updates on job applications, please go to the candidate login page and sign in to check your application status.If you need assistance completing your application please email [e-mail] request removal of your personal information from our systems please email [e-mail]