Associate Director, RA, Leading medical device company
|Job Title:||Associate Director, RA, Leading medical device company|
|Contact Name:||Cherry Zhu|
|Job Published:||September 07, 2017 10:33|
Our client, one top ranking medical device company, is seeking a Associate RA Director role. Profile Search & Selection is acting as Employment agency in relationship to this vacancy.
Job Title: Associate RA Director
Department: MD, RA
Reports To: Sr RA Director, JJMC
Principal Duties and Responsibilities (General Summary ，essential functions and authorities, etc.)
- Adherence to J&J credo and industry code of conduct, ethics and good regulatory practices, align team members with J&J credo. Ensure 100% compliance with local legislation, global regulatory policies, J&J credo.
- Providing guidance or advice, product development and registration strategy to relative Dept. according to micro & macro regulatory environment and the changes
- Leading and effective coaching RA teams to deliver product registration, improve efficiency and competency, building up high performance team
- Motivating and inspiring subordinates to work efficiently, engage into business
- Leading RA teams on shaping regulatory environment, taking the leading role in industry
- Strengthening collaboration with CFDA, provincial FDA, GB/YY standard technical committees and other external stakeholders such as government labs, industry associations
- Crisis management handling
- Bachelor degree or above on pharmaceutical or medical device related education or training.
- Above 10 years' experience in regulatory and/or R&D experience in health care industry.
- Above 7 years' experience in people management in health care industry.
Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
Skill Sets and/or Training and/or Certification for the Special Position
- Solid people management skill
- Good clear, strategic and critical thinking
- Business sense
- Good project management skill
- English fluent in reading, writing, speaking and listening
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