Regulatory Affairs Manager/Director
We are looking for a special person to work with a global team and take a hands-on role in our Regulatory Affairs department. This position is responsible to help assure compliance to applicable medical device state, federal, and international standards, regulations, laws and guidelines. The individual will provide regulatory support for product registration in the United States and Asian countries. The individual may assist in identifying data needed, compiling data, organizing and preparing regulatory documents for registration.
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THE IDEAL CANDIDATE
The candidate selected to fill this position will have:
- Bachelor’s or masters degree in a scientific discipline
- Minimum 8 years experience in the medical device industry. At least 4 years in Management position and 5 years in regulatory affairs role in a small medical device company
- RAC Certification
- Working knowledge with current revisions of global medical device regulations and standards
- Direct hands-on regulatory submission experience preparing technical documentation, 510(k)s, regulatory strategy documents, review product labeling for compliance for Class II medical devices
- Experience as regulatory affairs representative on product development teams.
- Experience in risk management reviews and providing guidance to team on risk management process to maintain compliance with current standards
- Evaluating and approving content of technical reports to ensure compliance with quality system and international regulations.
- Review labeling (including IFU), publications and promotional material
- Reviewing, investigating, and assessing complaints for reportability
THE REASONS TO JOIN US
- An opportunity to significantly impact the lives of millions of lung cancer patients
- A small, startup environment on the verge of growing into a global enterprise
- An extraordinary group of employees, advisors, and investors
- Equity participation, and competitive compensation and benefits
To apply, send your resume to firstname.lastname@example.org.
Job posted: 2020-10-16