Regulatory Affairs Manager

Medtronic • Boston, MA

3d • $120,800 - $181,200 • Hybrid

About The Position

The Regulatory Affairs Manager establishes worldwide product approval and submission strategies, directly executes submission activities focused on the U.S. and EU, and ensures regulatory compliance for products within Medtronic’s Surgical Operating Unit. The role uses hands-on leadership and delegation to individual contributors, partnering with business stakeholders to develop regulatory strategies that support business goals and translate them into team work plans. The position oversees the Stapling Regulatory Affairs team’s daily work and may take on direct people management as business needs evolve.

The position is onsite four days per week at a Surgical location: North Haven, Connecticut (preferred), Lafayette, Colorado, Mounds View, Minnesota, or Mansfield, Massachusetts. It involves leading or supporting regulatory work for product development and throughout the product lifecycle, including submission preparation, regulatory agency interactions, compliance reviews, team performance and development, and process improvement. The role also provides progress reports or presentations to senior management.

Requirements

• Bachelor’s degree required.
• At least 5 years of relevant experience, or an advanced degree and at least 3 years of relevant experience.
• For a baccalaureate degree earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice To Haves

• Five or more years of medical device regulatory affairs experience.
• Experience serving as a Regulatory Affairs lead for new product development projects.
• A degree in engineering or an advanced degree.
• A 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 EU MDR, and 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.
• Ability to prioritize work, manage time effectively, and meet project deadlines.
• Ability to work effectively in dynamic, cross-functional team environments.

Responsibilities

• May serve as the regulatory lead for one or more new product development projects.
• Oversee the day-to-day regulatory activities of the Stapling Regulatory Affairs team, with potential to assume direct people management responsibilities as business needs evolve.
• Participate in daily operations to meet schedules and resolve complex problems.
• Develop regulatory strategies for existing, new, and modified medical devices to meet business objectives, collaborating across a matrixed organization to support global product success.
• Collaborate with external regulatory authorities and cross-functional stakeholders to align regulatory strategies with business objectives.
• Lead interactions with regulatory agencies as part of strategy development and regulatory review support.
• Provide guidance on regulatory requirements for contingency planning and ensure compliance with 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.
• Oversee regulatory reviews of advertising and promotional materials to ensure product claims and materials align with applicable local guidance and regulations.
• Sponsor and monitor a high-performance management culture with clear employee performance expectations.
• Provide career coaching and feedback, and manage and develop team members at all experience levels.
• Communicate talent differentiation and align development actions and rewards accordingly.
• Conduct timely, 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 Operating Unit product submission goals.
• Improve operating mechanisms, communication pathways, and processes to increase efficiency.
• Direct or perform coordination and preparation of document packages for regulatory submissions, internal audits, and inspections across the company.
• Lead or compile 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.
• Keep abreast of regulatory procedures and changes.
• May direct interactions with regulatory agencies on defined matters.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive through the Medtronic Incentive Plan (MIP).
• For regular employees working 20 or more 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 the Simple Steps well-being program.
• For all regular employees: incentive plans; 401(k) plan with 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: Manager