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Regulatory Affairs Leader
Job Description Summary
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market
Roles and 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
- Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
- Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
- Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
- Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.
- For roles outside of the USA- This role requires advanced experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a Bachelor’s degree from an accredited university or college ( or a high school diploma with relevant experience).
- Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
Note:To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years’ experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.
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Job posted: 2022-07-10