Senior Regulatory Affairs Spec

Medtronic • Colorado Springs, CO

1d • $92,000 - $138,000

About The Position

At 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 At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Our Purpose This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results through providing guidance and mentorship to team members, supporting their development and helping them navigate complex regulatory requirements. Collaborate closely with cross-functional partners such as R&D, clinical, operations, and marketing to ensure regulatory needs are integrated into product development and lifecycle management. Occasionally represent the company in discussions with regulatory bodies and industry groups, supporting regulatory compliance and business objectives supporting Acute Care & Monitoring achieve regulatory success and maintain a competitive edge. Come for a job, stay for a career! A Day in The Life: The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Microstream™ Capnography Monitoring product portfolio within the Acute Care and Monitoring operation unit. Activities include participation in change development projects, review and approve design control documentation, regulatory change assessments, author regulatory documents (MDR Technical Documents, STEDs or 510ks) and supporting EU MDR implementation. The Sr. RAS role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices.

Requirements

• Level 8 Honor’s Degree Science or Engineering bachelor's degree/master's with a minimum of 5 years of relevant experience, preferably with Class III Medical Devices.
• Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required.
• You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
• You have strong technical knowledge.
• You are skilled in thinking critically and making sound decisions.
• Ability to comprehend principles of engineering, physiology, and medical device use.
• You collaborate with global cross functional teams and create alignment with team members.
• Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements.
• Experience with software and hardware medical devices.
• May provide guidance, coaching and training to other employees within job area.
• You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behavior.
• Ability to effectively manage multiple projects and priorities.
• Has an excellent attention to detail and are results oriented.
• Proven problem-solving skills with the ability to identify risks and escalate issues as appropriate.
• Good initiative and team player.

Nice To Haves

• A Regulatory Affairs qualification is desirable, but not mandatory.

Responsibilities

• Directs or performs coordination and preparation of document packages for regulatory submissions.
• Supports change control activities to support global approval and implementation of product and process changes.
• Leads or compiles all materials required in CE-Mark and FDA submissions, license renewal and annual registrations.
• Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products.
• Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
• Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
• Keeps abreast of regulatory procedures and changes.
• Develop internal procedures to ensure continuous compliance with all regulatory requirements.
• May have direct interaction with regulatory agencies on defined matters.
• Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
• Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.

Benefits

• Medtronic offer a competitive salary and flexible Benefits Package
• Medtronic offers a competitive Salary and flexible Benefits Package
• 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).
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level