Regulatory Affairs Manager

Medtronic • Lafayette, CO

14d • $120,800 - $181,200 • Onsite

About The Position

As the Regulatory Affairs Manager, you will be responsible for establishing strategies for worldwide product approval and submission activities, directly executing submission activities focused on the U.S. and EU, and ensuring regulatory compliance for Lung Health and Gynecologic products within the Surgical organization. The Regulatory Affairs Manager is expected to achieve results through hands-on leadership and the delegation of responsibilities to individual contributors. This role requires collaboration with business partners to develop regulatory strategies that support business goals and translate those strategies into work plans for the Regulatory Affairs teams. This position requires working onsite four days per week at one of our Surgical locations: Lafayette, CO; Mounds View, MN; North Haven, CT; or Mansfield, MA.

Requirements

• Bachelor’s degree required.
• Minimum of seven years of relevant experience or an advanced degree with a minimum of five years of relevant experience.

Nice To Haves

• Five or more years of medical device regulatory affairs experience.
• 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., European, and international regulations, including the EU MDR, as well as standards applicable to products of all risk classifications.
• Experience interacting with the FDA and/or other regulatory agencies, including Q-Submission preparation and meetings, submission issue meetings, and other interactions.
• Proven ability to prioritize work, manage time effectively, and meet project deadlines.
• Ability to work effectively in dynamic, cross-functional team environments.
• 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.

Responsibilities

• Oversee the day-to-day functions of the Lung Health and Gynecologic Regulatory Affairs team.
• Become actively involved in daily operations to meet schedules or resolve complex problems.
• Develop regulatory strategies for existing, new, and modified medical devices to meet business objectives, and collaborate across a matrixed organization to ensure the global success of products.
• Collaborate with external regulatory authorities and cross-functional stakeholders to ensure alignment of regulatory strategies with business objectives.
• Lead interactions with regulatory agencies as part of strategy development and the support of regulatory reviews.
• Provide guidance on regulatory requirements necessary for contingency planning and ensure compliance with all applicable regulations.
• Partner with quality, engineering, clinical, manufacturing, and commercial teams to ensure regulatory compliance throughout the product lifecycle.
• Manage team performance, resource planning, talent development, succession planning, and employee engagement initiatives.
• Provide oversight of regulatory reviews of advertising and promotional materials to ensure that product claims and materials align with applicable 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.
• Clearly identify and communicate talent differentiation, and ensure that development actions and rewards align accordingly.
• Conduct timely and candid performance evaluations and support meaningful development activities.
• Cultivate a safe, inclusive, and engaging work environment.
• Provide periodic progress reports or presentations to senior management regarding OU product submission goals.
• Continuously improve operating mechanisms, communication pathways, and processes to increase efficiency.
• Work with your team to ensure understanding and alignment of regulatory work to business goals and priorities.
• Direct or perform the coordination and preparation of document packages for regulatory submissions, internal audits, and inspections across all areas of the company.
• Lead or compile all materials required for submissions, license renewals, and annual registrations.
• Recommend changes to labeling, manufacturing, marketing, and clinical protocols to maintain regulatory compliance.
• Monitor and improve tracking and control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.

Benefits

• 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
• 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)
• 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: Manager