Manager, Regulatory Affairs
GE HealthCare
full-time
Posted on:
Location Type: Remote
Location: Wisconsin • United States
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Salary
💰 $132,000 - $198,000 per year
About the role
- Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally.
- Developing specialized depth and/or breadth of expertise in own job discipline or field.
- Serves as best practice/quality resource.
- Has awareness of latest functional developments in own area.
- Contributes towards strategy and policy development and ensures delivery within area of responsibility.
- Skilled influencer, able to communicate complex messages to others.
- Acts as a resource for colleagues with less experience.
- May lead small projects with moderate risks and resource requirements.
- Explains difficult or sensitive information; works to build consensus.
Requirements
- Bachelor's Degree in a Scientific or Engineering discipline or a minimum of 8 years work experience
- A minimum of 4 years Regulatory Affairs / Quality Assurance experience
- A minimum of 4 years' experience in the medical device or pharmaceutical industry
- Strong experience with management of regulatory projects in global regulatory organizations and working globally across different cultures
- Excellent verbal and written communication and presentation skills with ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements.
Benefits
- medical, dental, vision
- paid time off
- 401(k) plan with employee and company contribution opportunities
- life, disability, and accident insurance
- tuition reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Regulatory AffairsQuality AssuranceRegulatory StrategyPremarket SubmissionsPost Market ComplianceProject ManagementMedical Device IndustryPharmaceutical IndustryGlobal Regulatory Organizations
Soft skills
InfluencingCommunicationPresentation SkillsConsensus BuildingCollaboration
Certifications
Bachelor's Degree in Scientific DisciplineBachelor's Degree in Engineering Discipline