Sr Regulatory Affairs Manager

Medtronic • Lafayette, CO

1d

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 As the Regulatory Affairs Manager, you will be responsible for establishing strategy for worldwide product approval submission activities, directly responsible for execution of submission activities focused on US/EU and for ensuring regulatory compliance for Acute Care and Monitoring products. The Regulatory Affairs manager is expected to accomplish results through hands on and delegation of responsibility to individual contributors. This role will require collaboration with business partners to develop regulatory strategies to support the business goals and translate the strategies into work plans for the Regulatory Affairs teams to implement 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. Location: Prefer candidate to be in Lafayette, CO. Responsibilities may include the following and other duties may be assigned.

Requirements

• Bachelor’s Degree with and minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• While performing the duties of this job, the employee is regularly required to be independently mobile.
• The employee is also required to interact with a computer, and communicate with peers and co-workers.

Nice To Haves

• 5+ years of medical device regulatory affairs experience
• 1+ year of previous experience with direct reports
• Degree in Engineering or an Advanced degree.
• Proven track record of leading high performing teams
• Ability to recognize and develop key talent
• Excellent knowledge of U.S. and European/International regulations, including EU MDR, and standards for all risk classifications of products
• Experience interacting with FDA and/or other regulatory agencies such as Q-sub preparations and meetings, submission issue meetings and other interactions.
• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Must work well in dynamic and cross functional team environments.

Responsibilities

• Provides direction, leadership and coaching to specialists to meet schedules and resolve technical or operational problems.
• Becomes actively involved in daily operations to meet schedules or to resolve complex problems.
• Develop global regulatory strategies for Acute Care and Monitoring products to meet business objectives and collaborate across a matrixed organization to ensure global success of products
• Collaboration with external regulatory authorities and cross-functional stakeholders to ensure alignment of regulatory strategy with business objectives.
• Leading interactions with regulatory agencies as part of strategy development and support of regulatory reviews.
• Providing guidance on regulatory requirements necessary for contingency planning and ensuring compliance with all applicable regulations.
• Provide oversight of regulatory review of advertising and promotion materials to ensure appropriateness of product claims and materials in alignment with local guidance and regulations
• Sponsor and actively monitor a high-performance management culture where employees have clear performance expectations.
• Provide targeted career coaching and feedback; manage and develop team members at all levels of experience from entry[1]level to Principal. Clearly identify and communicate the differentiation of talent and assure development actions and rewards align accordingly. Conduct timely and candid performance evaluations. Support meaningful development activities. Cultivates a safe, inclusive and engaging work environment
• Provide reports or present to Senior Management on progress to OU product submission goals on a periodic basis.
• Provide Regulatory Guidance as a functional leader on new product registration, modified products, transferred products, and acquisition activities.
• Continuously improve operating mechanisms, communication pathways and processes for efficiency
• Work with your team to ensure understanding and alignment of regulatory work to business goals and priorities.
• 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.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.

Benefits

• 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: Entry Level