Regulatory Affairs Manager
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 Lung Health and Gynecologic products within the Surgical organization. The role achieves results through hands-on leadership and delegation, collaborating with business partners to develop regulatory strategies that support business goals and translate those strategies into team work plans. This position works onsite four days per week at one of the following Surgical locations: Lafayette, Colorado; Mounds View, Minnesota; North Haven, Connecticut; or Mansfield, Massachusetts. The manager oversees day-to-day team operations, regulatory strategy and submissions, regulatory agency interactions, product-lifecycle compliance, and team performance and development. The role also communicates progress on submission goals to senior management and continuously improves processes and operating mechanisms.
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 baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Nice To Haves
- Five or more years of medical device regulatory affairs experience.
- 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.
- Proven ability to prioritize work, manage time effectively, and meet project deadlines.
- Ability to work effectively in dynamic, cross-functional team environments.
Responsibilities
- Oversee day-to-day functions of the Lung Health and Gynecologic Regulatory Affairs team, participating 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 in support of strategy development and regulatory reviews; may direct agency interactions on defined matters.
- Guide contingency planning for regulatory requirements and ensure compliance with applicable regulations.
- Partner with quality, engineering, clinical, manufacturing, and commercial teams to maintain regulatory compliance throughout the product lifecycle.
- Manage team performance, resource planning, talent development, succession planning, and employee engagement.
- 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 team members, communicate talent differentiation, and conduct timely performance evaluations that support development and rewards.
- Cultivate a safe, inclusive, and engaging work environment.
- Provide progress reports or presentations to senior management on organizational-unit product submission goals.
- Improve operating mechanisms, communication pathways, processes, and tracking and control systems to increase efficiency.
- Align regulatory work with business goals and priorities.
- Direct or perform coordination and preparation of document packages for regulatory submissions, internal audits, and inspections across company areas.
- Lead or compile materials for submissions, license renewals, and annual registrations.
- Recommend changes to labeling, manufacturing, marketing, and clinical protocols to maintain regulatory compliance.
- 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/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, available to 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
