Medtronic este o companie globală de tehnologie medicală și producție, care dezvoltă soluții pentru afecțiuni medicale complexe. Activitatea sa reunește echipe internaționale numeroase și o colaborare strânsă cu profesioniștii din domeniul sănătății pentru a îmbunătăți tratamentele, terapiile și accesul la tehnologia medicală. Cu peste 95.000 de angajați în mai mult de 150 de țări, Medtronic se concentrează pe dezvoltarea îngrijirii pacienților, susținând totodată incluziunea, diversitatea, echitatea și practicile sustenabile în cadrul operațiunilor sale.
Senior Medical Device Regulatory Affairs Manager – Medtronic, Lafayette, CO (Hybrid)
Lead global regulatory strategy, submissions, and compliance for Medtronic’s Lung Health and Gynecologic medical-device products. Manage regulatory teams and agency interactions across U.S., European, and international markets.
Descriere
- Set global strategies for product approvals and regulatory submissions
- Execute regulatory submissions primarily for the United States and European Union
- Maintain regulatory compliance for Lung Health and Gynecologic products within the Surgical organization
- Oversee the daily operations of the Lung Health and Gynecologic Regulatory Affairs team
- Support operational priorities, schedule adherence, and resolution of complex issues
- Create regulatory strategies for existing, new, and modified medical devices
- Work across a matrixed organization to support global product success
- Coordinate with regulatory authorities and cross-functional stakeholders
- Lead agency engagement during strategy development and regulatory reviews
- Advise on regulatory requirements for contingency planning and compliance
- Partner with quality, engineering, clinical, manufacturing, and commercial teams across the product lifecycle
- Direct team performance, resource planning, talent development, succession planning, and employee engagement
- Oversee regulatory assessment of advertising and promotional materials
- Champion and track a high-performing management culture
- Coach employees and provide feedback, performance reviews, and development support
- Build a safe, inclusive, and engaging workplace
- Present progress updates to senior management on product submission objectives
- Strengthen operating models, communication channels, and business processes
- Coordinate document packages for submissions, internal audits, and inspections
- Lead or assemble materials for submissions, license renewals, and annual registrations
- Recommend updates to labeling, manufacturing, marketing, and clinical protocols
- Monitor and enhance regulatory tracking and control systems
- Stay current on regulatory procedures and changes
- Interact directly with regulatory agencies on assigned matters
Cerințe
- Bachelor’s degree required
- At least seven years of relevant experience, or an advanced degree with at least five years of relevant experience
- Five or more years of experience in medical-device regulatory affairs
- Engineering degree or advanced degree
- Demonstrated success leading high-performing teams
- Ability to identify and develop key talent
- Strong knowledge of U.S., European, and international regulations, including EU MDR, and standards covering products across risk classifications
- Experience working with the FDA or other regulatory agencies, including Q-Submission preparation, meetings, submission-issue meetings, and related interactions
- Ability to prioritize effectively, manage time, and deliver against project deadlines
- Ability to work successfully in dynamic, cross-functional environments
- A baccalaureate degree earned outside the United States must meet the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)
- Unrestricted U.S. work authorization is required at hire and throughout employment
Beneficii
- 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-care spending account
- Tuition assistance or reimbursement
- Simple Steps global well-being program
- Incentive plans
- 401(k) plan with employer contribution and matching
- Short-term disability coverage
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Supplemental non-qualified retirement plan
- Capital Accumulation Plan for eligible Vice Presidents and employees meeting applicable IRS earning thresholds
- Temporary employees receive paid sick time where required by applicable state law
- Employee Stock Purchase Plan for temporary employees
- Reasonable accommodations for qualified individuals with disabilities