Head of Regulatory Affairs

🔎 Title: Team Lead Regulatory Affairs Consulting📍 Location: Switzerland - with flexible hybrid options✉️ Contact: frankie@elemed.eu🔸 The CompanyThis is your chance to join a solutions-oriented medtech advisory company with a personal approach to its customers. Founded around 10 years ago, this company has grown quickly and gone from strength to strength providing high-quality, in-depth and tailored solutions to medical device manufacturers of all sizes, supporting them to expand internationally. Patient safety is at the centre of everything they do and is driven by the supportive teams they have in Quality, Clinical, Product Development, and Regulatory functions.🔹 The OpportunityAs the Team Lead for Regulatory Affairs Consulting you will help to build a pipeline of projects, new clients, and work closely with existing clients from start-ups to large multinationals to support them in achieving regulatory approval for various products including drug-device combination devices! You will work with startups that require full technical documentation preparation, as well as larger companies that need support on resolving particular regulatory hurdles. There is also the need to build and strength the regulatory department to replicate the successes seen by the Quality and the Clinical teams over the past year. You will also be leading the RA team growth strategy from current 3 people up to 15 people.🔸 Responsibilities:Provide regulatory technical advice and guidance to client manufacturers to get medical devices faster to patients in international markets (strong focus on EMEA, North America)Independently drive new business opportunities, take ownership in building a pipeline of new projects and new client companies for regulatory advisory servicesLead a RA team of consultants and creating team growth plansManage various projects and project timelines with several client companiesTake ownership of client relationshipsPerforming document reviews, gap assessments to determine what supplementary information if neededAuthoring the technical file for the customer's products to be compliant with MDD/MDR and FDA submissionsSupporting on submission strategy for various products including combination, substance-based, AI and software medical devicesCoordinating and managing authorisation procedures and interactions with notified bodiesMaintain and ensure existing licenses are compliant with local regulations for client product portfolios🔹 Your qualifications:We are looking for strong regulatory professionals with medical device experience, who are experienced with strong leadership skills, passion for bringing medical devices faster to patients and have good attention to detail. We would love to hear from you if you have:Minimum 15+ years of experience in the medical device industry in RA and RA leadership rolesExperience in both medical device manufacturer and also advisory/consulting companiesDegree level scientific backgroundEnglish language skills (German will be a plus)✉️ If you are interested in this exciting role, please send your application directly to frankie@elemed.eu📲 Would you like to find out more about our open opportunities? Visit https://www.elemed.eu/vacancies/Please note: Only candidates meeting the requirements set out in the role profile above, will be considered in the application process. Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful. ___________________________________________________________________🩺 Elemed is Europe’s leading MedTech technical recruiter. We serve within the Medical device, diagnostic and combination device arena, working with Managers up to VP of Quality and Regulatory. Our team helps medical device experts of today become leaders of tomorrow.📣 We won Best International Recruitment Agency at the Recruiter Awards 2021.At Elemed, we recruit exceptional people that solve regulatory and compliance problems, so patients can have access to safe, innovative and life-changing Medical Devices.⚖️ We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.