Regulatory Affairs Lead
GE Healthcare
Employer Active
Posted 5 hrs ago
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
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 in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.
Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.
Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
Desired Candidate Profile
- Pharmacist degree or Master s degree in a scientific discipline from an accredited university or college.
- Significant experience in Regulatory Affairs within medical device industry, including regional or global roles.
- Advanced knowledge of applicable regional and international regulatory frameworks and postmarket requirements.
Company Industry
- Medical
- Healthcare
- Diagnostics
- Medical Devices
Department / Functional Area
- Administration
Keywords
- Regulatory Affairs Lead
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