## Spécialiste principal des Affaires réglementairesPostulerremote type: Sur sitelocations: Lafayette, Colorado, United States of America: Mansfield, Massachusetts, United States of America: Mounds View, Minnesota, United States of America: North Haven, Connecticut, United States of America: Boston, Massachusetts, United States of Americatime type: Temps pleinposted on: Offre publiée aujourd'huitime left to apply: Date de fin : 21 août 2026 (Il reste 14 jour(s) pour postuler)job requisition id: R73244We anticipate the application window for this opening will close on - 21 Aug 2026Chez Medtronic, vous pouvez entamer une longue carrière d’exploration et d’innovation tout en aidant à soutenir l’accès aux soins de santé et l’équité pour tous. Vous dirigerez avec détermination en surmontant les obstacles à l’innovation dans un monde davantage connecté et compatissant.**Journée type**The Principal Regulatory Affairs Specialist develops and executes strategies for global regulatory approvals to introduce new and modified medical device products to the market. The Principal Regulatory Affairs Specialist translates regulatory requirements into project/product requirements, prepares worldwide regulatory submissions and negotiates their approval. Responsibilities include participating on product development teams, developing global regulatory strategies, preparing US and international regulatory submissions, supporting pre and post market regulatory compliance activities and evaluating proposed product changes for regulatory impact and preparing necessary documentation. Responsibilities may include the following and other duties may be assigned.* Develop and implement comprehensive global regulatory strategies for medical device submissions to ensure timely market access for New Product Development* Author regulatory submissions, including but not limited to pre-submissions, premarket notifications (510(k)s), EU change notifications, and technical documentation.* Serve as a key regulatory representative on cross-functional product development teams, providing strategic input, timelines, and direction.* Review and approve product labeling, training materials, promotional content, and advertising for regulatory compliance.* Support global pre-market and post-market regulatory activities to maintain product approval and lifecycle compliance.* Oversee and coordinate multiple regulatory projects across domestic and international markets.* Provide strategic leadership and mentorship to Regulatory Affairs Specialists in the development of regulatory submissions and interpretation of global regulations.* Lead or coordinate the preparation of regulatory submission documentation, as well as internal audit and inspection readiness activities.* Recommend and implement changes to labeling, manufacturing processes, marketing strategies, and clinical protocols to ensure regulatory compliance.* Monitor and enhance regulatory tracking and control systems to drive process efficiency and documentation integrity.* Maintain up-to-date knowledge of evolving global regulatory requirements, guidance, and industry best practices.* Interface with regulatory authorities as required on defined matters, ensuring effective communication and resolution of issues.* Actively participate in internal and external audits, providing subject matter expertise as needed.* Review of promotional and advertising material.**Must Have: Minimum Requirements*** Bachelors degree with 7+ years of regulatory affairs experienceOR* An advanced degree with 5+ years of regulatory affairs experience**Nice to Have*** 7+ years of medical device regulatory affairs with roles showing increasing responsibility* Experience with FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards* Strong leadership and team management skills.* Excellent communication and interpersonal skills.* Ability to thrive in a fast-paced, collaborative environment.* Strong problem-solving and decision-making abilities.* Experience with Notified Body audits.* Collaboration and leadership skills in team setting including ability to coach and develop team members, and effective resource management to address multiple priorities.* RAC credential preferred* Strong interpersonal, analytical, writing, and organizational skills, including the ability to “navigate the grey”* Ability to analyze and resolve non-routine regulatory issues using independent judgment* Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations* Demonstrated history of successful regulatory submissions in the US and EU* Experience with software-enabled medical devices, including artificial intelligence and machine learning technologies, as well as clinical trials and preclinical testing.Pour les diplômes de baccalauréat obtenus en dehors des États-Unis, un diplôme qui satisfait aux exigences de la réglementation 8 C.F.R. § 214.2 (h) (4) (iii) (A) est requis.**Exigences physiques du poste**Les déclarations ci-dessus visent à décrire la nature générale et le niveau du travail effectué par les employés affectés à ce poste, mais elles ne constituent pas une liste exhaustive de toutes les responsabilités et compétences requises pour ce poste.Les exigences physiques décrites dans la section Responsabilités de cette fiche de poste sont représentatives de celles auxquelles un employé doit satisfaire pour remplir correctement les fonctions essentielles du poste. Des ajustements raisonnables peuvent être apportés pour permettre aux personnes en situation de handicap de remplir ces fonctions essentielles. Rôles administratifs : dans l’exercice de ses fonctions, l’employé est régulièrement appelé à se déplacer de façon autonome. Il est également amené à utiliser un ordinateur et à communiquer avec ses pairs et ses collègues. Contactez votre responsable ou votre service RH local pour connaître les conditions de travail et les exigences physiques spécifiques à chaque rôle.**Autorisation de travail et parrainage** Chez Medtronic, nous nous engageons à favoriser un environnement dans lequel les employés peuvent s'épanouir et avoir un impact significatif. Conformément à notre approche de planification de la main-d'œuvre à l'échelle de l'entreprise, le parrainage d'autorisation de travail aux États-Unis (H-1B, TN, J, etc.) est proposé exclusivement pour les postes de niveau Principal et supérieur, où l'expertise spécialisée s'aligne sur les besoins métier à long terme. Les postes en dessous du niveau Principal exigent que les candidats possèdent une autorisation de travail américaine sans restriction au moment de l'embauche et pour la durée de l'emploi. Rejoignez-nous et aidez-nous à accomplir notre mission, à savoir soulager la douleur, rétablir la santé et prolonger la vie, en valorisant votre expérience et votre perspective uniques.**Recruitment Fraud Alert**We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at **Avantages sociaux et rémunération****Medtronic offre un salaire compétitif et un ensemble d’avantages sociaux flexibles** Le cœur de nos valeurs est animé par un engagement envers nos employés. Nous saluons leurs contributions et partageons avec eux le succès qu’ils ont contribué à créer. Nous offrons un large éventail d’avantages, de ressources et de régimes de rémunération concurrentiels conçus pour vous soutenir à chaque étape de votre carrière et de votre vie personnelle.Salary ranges for U.S (excl. PR) locations (USD):$120,000.00 - $180,000.00This 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:Avantages sociaux et plans de rémunération de Medtronic
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