Regulatory Affairs Manager
About The Position
The Regulatory Affairs Manager establishes strategies for worldwide product approvals and submissions, directly executes U.S. and EU submission activities, and ensures regulatory compliance for products within the Surgical Operating Unit. The role combines hands-on leadership with delegation and collaboration across business partners to develop regulatory strategies supporting business goals and translate them into team work plans. The position is onsite four days per week at a Surgical location: North Haven, Connecticut (preferred), Lafayette, Colorado, Mounds View, Minnesota, or Mansfield, Massachusetts. The role oversees the day-to-day regulatory activities of the Stapling Regulatory Affairs team and may take on direct people-management responsibilities as business needs evolve. It works across the product lifecycle with regulatory authorities and internal teams, and may serve as regulatory lead for new product development projects. The manager also develops team capability and performance, provides progress updates to senior management, and coordinates regulatory submission documentation, audits, inspections, license renewals, and annual registrations. The role recommends changes needed to maintain compliance and monitors regulatory procedures and applicable requirements.
Requirements
- Bachelor’s degree required.
- At least 5 years of relevant experience, or an advanced degree with at least 3 years of relevant experience.
- For baccalaureate degrees 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.
- 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 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
- Establish worldwide product approval and submission strategies, and directly execute submission activities focused on the U.S. and EU.
- Ensure regulatory compliance for products within the Surgical Operating Unit.
- Translate regulatory strategies into work plans for Regulatory Affairs teams and collaborate with business partners to support business goals.
- May serve as regulatory lead for one or more new product development projects.
- Oversee the day-to-day regulatory activities of the Stapling Regulatory Affairs team; potentially 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 and collaborate across the organization to support global product success.
- Collaborate with regulatory authorities and cross-functional stakeholders to align regulatory strategies with business objectives.
- Lead interactions with regulatory agencies in support of strategy development and regulatory reviews; may direct agency interactions on defined matters.
- 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 comply with local guidance and regulations.
- Set clear performance expectations, coach and provide feedback to employees, and conduct timely performance evaluations and development activities.
- Identify and communicate talent differentiation and align development actions and rewards accordingly.
- Cultivate a safe, inclusive, and engaging work environment.
- Provide periodic progress reports or presentations to senior management regarding 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.
- 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.
Benefits
- Competitive salary and flexible benefits package.
- Short-term incentive through the Medtronic Incentive Plan (MIP).
- Health insurance.
- Dental insurance.
- Vision insurance.
- Health Savings Account.
- Healthcare Flexible Spending Account.
- Life insurance.
- Long-term disability leave.
- Dependent daycare spending account.
- Tuition assistance or reimbursement.
- Global well-being program (Simple Steps).
- 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.
- Capital Accumulation Plan for Vice Presidents and above, or subject to IRS earning minimums.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
