Associate Regulatory Affairs Specialist

Associate Regulatory Affairs Specialist page is loaded## Associate Regulatory Affairs Specialistremote type: Hybridlocations: Watford, Hertfordshire, United Kingdomtime type: Full timeposted on: Posted Todayjob requisition id: R41879At 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 is among the largest medical technology companies in the world. Through innovation and collaboration, Medtronic helps to alleviate pain, restore health and extend life. Last year, our medical therapies for the treatment of over 40 major conditions, improved the lives of more than 75 million people around the world. We are looking for an entry level Associate Regulatory Affairs Specialist for post-market regulatory product support including field safety corrective actions, competent authority requests for information, complaint process support, product documentation and support requests from customers, sales and tenders teams, and other internal stakeholders. You will get the benefit of hybrid work – Tuesdays and Wednesdays from Watford, UK office and the rest of the week from home.**Responsibilities may include the following and other duties may be assigned:*** Preparation, execution and follow up of FSCA (field safety corrective actions) according to the enterprise plan. Close collaboration with the sales managers and sales representatives to collect/record evidence, allowing timely closure of the UK/Ireland Field Actions. Reconciliation activities in collaboration with the FCA Support Team.* Follow up on inquiries from the Competent Authority to i.e., Field Action or Vigilance activities. This includes updating the Medtronic reporting systems and record keeping.* Support on Post-Market Surveillance – provide advice to sales team members on product complaint handling processes and returns, to assure compliance to UK/Ireland Regulations and Medtronic procedures* Monitors the shared mailbox by providing support to tender requests, customer requests, internal stakeholder requests* Sourcing, verifying and providing regulatory documents to customers and other stakeholders* Connecting requests to the appropriate Organizational Unit and ensuring complete follow up* Maintaining training completion, participation in team and process improvement initiatives**Required Knowledge and Experience:*** Degree in Engineering, Life-science, Biology or another relevant advanced degree OR 3-5 years of medical device regulatory experience* Advanced computer skills (Microsoft Office including advanced Excel skills and ability to use custom organizational software)* Critical Thinking and problem solving* Autonomy and proactivity, continuous learning, attention to detail* Organizational and strong administrative skills, including self- organisation and task tracking* Clear communication, proficient English language to allow for stakeholder management and influencing* Quality orientation and patient safety focused, curiosity and high interest in the medical device field**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 AskHR@medtronic.comTo request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com #J-18808-Ljbffr