Regulatory Director

The primary responsibilities include creating regulatory strategy for new products, managing filing related activities, providing regulatory expertise on daily issues, and interfacing with outside regulatory agencies. Manage assigned product registration activities; including filing determinations, and annual license renewals, compile information from multiple sources for filing, guiding the project teams in creating documentation for submission, writing summaries and other necessary documentation for filing. This position reports to the President of the Japanese branch and to the Global Regulatory Director.

Duties & Responsibilities:

- Represent Regulatory Affairs on project team.
- ?Attend product project teams meetings, as necessary, providing regulatory guidance and review.
- Prepare annual facility establishment licensing renewals and product listings
- Prepare necessary product registration renewals when required.
- Establish quality system related procedures and policies for Regulatory Affairs.
- Possess a broad understanding of the quality system regulations for medical devices.
- Develop regulatory strategies, templates and documentation for product registrations for each new or modified product.
- Assist management in planning regulatory activities, identifying road blocks, strategizing on various regulatory paths for new products.
- Actively participate with product risk management for medical devices teams.
- Provide guidance in complying with regulations; assist in developing rationale and documentation for new product development, design verification, product changes, testing, design reviews, labeling changes, packaging changes, material changes, etc.
- Review and approve product labeling content
- Review and approve Marketing advertising and promotional materials
- Assist with product safety determinations
- Conduct product corrections and removals in a timely manner
- Assist with interfacing with FDA on regulatory issues; Interface with international regulatory agencies
- Participate with internal & external audits
- Work with Quality, Engineering, and Marketing to ensure product supply

-To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Pharmaceutical Licence highly desirable
- RAPS a plus
- 5-8 years in a regulatory role at a medical device company
- Extensive experience in performing all regulatory functions such as writing filing, reviewing documentation for regulatory compliance, interfacing with PMDA,
- Extensive experience with maintaining Technical files
- In depth knowledge of regulations
- Computer skills including Word and Excel
- Ability to work independently
- Team player – project team experience
- Ability to do research and come up with creative solutions for regulatory challengesExcellent writing skills and ability to synthesize information to present internally as well as to regulatory agencies
- Demonstrated leadership; attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects simultaneously

Education

- BS in Engineering or Science or equivalent (pharmaceutical preferred)
- Pharmaceutical Licence highly desirable

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