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Senior Regulatory Affairs Specialist.
4 months ago
Senior Regulatory Affairs Specialist – Acute Care & Monitoring
The Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and Europe. This position is also responsible for the regulatory global strategy, review of design changes, manufacturing changes and specification changes.
Location: There is a strong preference for candidates to be on-site in Boulder, CO. We will consider candidates to work remotely from the U.S.
Operating Unit
The newly created ACM OU is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth. The ACM OU R&D organization is refining its product delivery, innovation, and commercialization approach to enable product leadership across all segments of our product portfolio. This will require enhancing our innovation processes, refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM. ACM is a $2B global business focused on airway management and patient monitoring technologies.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
A Day in the Life
Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare FDA submissions and CE Mark Technical Files (MDD and MDR) for product changes and/or new products as required to ensure timely approvals for market released products. Provide support to currently-marketed products as necessary. This includes reviewing product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status. May interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager. Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel. Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work. Support post market regulatory compliance activities for US/EU product approvals. Develop and maintain regulatory affairs department procedures and process improvements Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct Assist in keeping company informed of regulatory requirements in the US and EU. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Leads or compiles all materials required in submissions, license renewal and annual registrations. Other duties as assigned Must Have: Minimum RequirementsBachelor'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 submission experience. U.S. and EU regulatory submission experience (510k and EU MDR) Experience with international standards (ISO, GHTF, ICH). Experience with FDA and international regulatory agency requirements, CE marking (MDR and MDD). Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483) and/or Pharmaceutical GMP (21 CFR 210/211). Experience working with cross-functional teams. Experience working with technical documentation. Project management skills. Product development experience. Knowledge of Medtronic procedures and systems. Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment. Strong oral and written communication skills. Effective interpersonal skills. Effective team member. Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills. Ability to effectively manage multiple projects and priorities. Proficient skills with MS Word, MS Outlook, MS Excel. Experience with Agile
