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About the role
Key responsibilities & impact- Accountable for the end-to-end field action process for the MMS business unit
- Timely execution of field actions within North America while aligning and coordinating with Regional PMQ Representatives from EMEA, LATAM and Greater Asia
- Conducting timely Field Action Committee (FAC) meetings
- Providing customer and regulator input into FAC decisions
- Ensuring FAC decisions align with regulator expectations
- Field action documentation creation
- Monitoring field action reconciliation
- Guiding PMQ Field Action Operations organization
- Driving global alignment on field action strategy and execution expectations in partnership with regional PMQ representatives
- Use of metrics and data analytics to assess field action execution and effectiveness
- Coordination with regulatory bodies as needed
- Audit Support for field actions and related decisions.
Requirements
What you’ll need- BA/BS degree or equivalent in a Life Science, Engineering, Physical Science, Nursing with an advanced technical degree; MBA preferred
- Minimum of 10 years of experience in quality & regulatory management within an FDA/Competent Authority regulated environment
- Comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device and / or in vitro diagnostics industries
- Strong preference for FDA Class II and Class III medical device and / or in vitro diagnostics experience
- Excellent written and oral communication and organizational, project management skills
- Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence
- High level of problem identification, analysis, and formulation of conceptual / technical and business solutions
- Knowledge of product failure modes.
- Strong knowledge of influencing, coaching, and people development principles
- Expertise in conducting and participating in both internal and external audits.
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
- Professional development opportunities
- Employee recognition programs
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data analyticsfield action documentationquality managementregulatory managementprocess excellenceaudit supportproblem identificationconceptual solutionstechnical solutionsbusiness solutions
Soft Skills
written communicationoral communicationorganizational skillsproject managementleadershipcoachingpeople developmentproblem analysiscontinuous improvementinfluencing
Certifications
BA/BS degreeadvanced technical degreeMBA