Regulatory Sales Specialist
Redwood City, CA
Responsibilities and Capabilities:
- Plan, coordinate and prepare documents packages for regulatory submissions, both nationally and internationally, including but not limited to FDA submissions, technical file/design dossiers, and registrations.
- Support development and implementation of regulatory strategies for new and modified products.
- Responsible for foreign registrations and “Permission to Export” documents.
- Maintain submission correspondence files and other regulatory files in a complete and secure manner.
- Create project deliverables, aligned with appropriate internal and external guidance documents.
- Maintain annual facility registration and device-listing documents.
- Ensure that existing approvals and documents are maintained.
- Provide regulatory input in quality system assessments, change control, and product development.
- Review test protocols to support regulatory submissions.
- Bachelor's degree and a minimum of 5 years’ experience in the medical device industry
- Demonstrated project management skills and experience.
- Proficient in timely review of technical data.
- Demonstrated success in fast pace start-up, entrepreneurial work environment.
- Ability to write clear, concise, and well thought out technical documents.
- Good presentation skills.
- Strong organizational and interpersonal skills
- Computer skills: MS Word, PowerPoint, Adobe Acrobat Professional, Excel
- The person will be expected to follow and support all Company policies and procedures
- The person must ensure their activities and those of their staff are in compliance with all legal and regulatory requirements applicable to the product lines and markets in which the Company participates