Job Description

Senior Regulatory Affairs Specialist - ACM Senior Regulatory Affairs Specialist - ACM Locations: Lafayette, Colorado, United States of America; Mounds View, Minnesota, United States of America; Mansfield, Massachusetts, United States of America Time type: Full time Posted on: Vor 4 Tagen Application Deadline: 9. April 2025 Ein Tag im Leben We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and Monitoring (ACM). In this role, you will play a key role in the lifecycle management of Medtronic products that get integrated with our strategic partners. You will be responsible for engaging with strategic partners in integration projects, preparing and submitting regulatory filings for the U.S. and EU market, and managing global compliance. You will collaborate closely with engineering, marketing, clinical, quality, as well as the regional and international teams working with integration partners to support the submission process and ensure regulatory requirements are met. Location: This is a hybrid role and we will not consider candidates to work remotely. The team has a strong preference for candidates to work hybrid from Lafayette, CO but will also consider candidates to work hybrid from Mounds View, MN / Mansfield, MA. Responsibilities: Participate in negotiations and interactions with regulatory authorities during the development and review process. Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements, and communicate that information to the business team. Support international product registrations as needed. Manage multiple projects and prioritize tasks on a day-to-day basis to meet project schedules. Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities. Review promotional and advertising material. Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards. Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements. Participate in internal and external audits as needed. Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements. Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections. Lead or compile all materials required in submissions, license renewal, and annual registrations. Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitor and improve tracking/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. Additional tasks as assigned. Required Knowledge and Experience: Bachelor’s degree with 4+ years of experience in regulatory affairs. OR an advanced degree with 2+ years of experience in regulatory affairs. Nice to Have: 4+ years of medical device regulatory affairs experience. Local to CO and willing to work hybrid for this role. Knowledge of FDA and EU MDR requirements. Experience of working with all classifications of product in the U.S. and/or EU. Background or coursework in quality systems, including familiarity with ISO standards (e.g., ISO 13485), and experience with Quality Management Systems (QMS). Technical Writing. International medical device regulatory submission/approval experience, including FDA and EU (specifically EU MDR). Product Labeling requirements and standards. May have practical knowledge of project management. Systems Knowledge such as RA systems, Agile, SharePoint, or Quality Management Systems. Experience working with OEMs or strategic partners. Experience working on integrations. Physische Jobanforderungen: Die obigen Angaben sollen die allgemeine Art und das Niveau der Arbeit der Mitarbeitern in einer solchen Position beschreiben, es handelt sich aber dabei nicht um eine vollständige Liste aller für diese Position erforderlichen Aufgaben und Fähigkeiten. Die im Abschnitt „Aufgaben“ dieser Stellenbeschreibung beschriebenen körperlichen Anforderungen sind repräsentativ für die Anforderungen, die ein Mitarbeiter erfüllen muss, um die wesentlichen Funktionen dieser Stelle erfolgreich auszuführen. Es müssen zumutbare Hilfsmaßnahmen unternommen werden, um Personen mit Behinderung die Ausübung der wesentlichen Funktionen zu ermöglichen. Leistungen und Vergütung: Medtronic bietet ein wettbewerbsfähiges Gehalt und ein flexibles Leistungspaket. Das Engagement für unsere Mitarbeiter ist der Kern unserer Werte. Wir schätzen die Beiträge jedes einzelnen. Sie tragen damit zu unserem Erfolg bei. Wir bieten für jede Karriere- und Lebensphase umfassende Leistungen, Ressourcen und wettbewerbsfähige Vergütungspläne. Salary ranges for U.S (excl. PR) locations (USD): $88,800.00 - $133,200.00. This 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. 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 Leistungs- und Vergütungspläne Über Medtronic: Wir sind weltweit führend im Bereich Gesundheitstechnologie und suchen und finden Lösungen für die drängendsten medizinischen Probleme der Menschheit. Unsere Mission, Schmerzen zu lindern, die Gesundheit von Patienten wiederherzustellen und ihr Leben zu verlängern, eint ein weltweites Team von mehr als 95.000 engagierten Mitarbeitern. Im Herzen sind wir Ingenieure, die ehrgeizige Ideen umsetzen, um echte Lösungen für echte Menschen zu entwickeln. • Erfahren Sie mehr über unser Engagement für Diversität und Inklusion. #J-18808-Ljbffr Medtronic

Job Tags

Similar Jobs