Regulatory Affair/Quality Project Manager - Device
Proclinical is currently recruiting for a Regulatory Affair/Quality Project Manager with a medical device company located in Milpitas, CA. The primary responsibility of this individual is to administer day-to-day Regulatory Affairs department activities by directly or indirectly managing individual employees, teams of employees, or third-party vendors. In addition, these roles exhibit a high degree of independent judgment and execute on plans that directly impact the operational results of business units.
- Provide tactical and strategic regulatory leadership to the organization and oversees regulatory aspects of new product development and launches including the preparation and submission of required global regulatory submissions
- Interpret regulatory requirements and oversees aspects of submission of licenses and authorizations for the maintenance of existing products, international registrations and dossiers including assessment of the impact product changes have on the status of regulatory licenses
- Independently make decisions regarding work processes or operational plans and schedules
- Provide day-to-day instructions and suggested training activities to direct reports; assigns projects or activities to individual contributors
- Represent regulatory affairs in cross-functional project teams and plans schedules for regulatory deliverables on a project and monitors project through completion
Skills and Requirements:
- Bachelor's Degree
- Minimum of 10 years related work experience
- Equipment usage and abilities needed:
* Proper application of Title 21 of the US Code of Federal Regulations
* Proper application of Part 800-1299 (21 CFR 800-1299)
* Proper application of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k), PMA
* Proper application of European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC)
* Proper application of Quality Management System Standard ISO 13485
* Proper application of Risk Management Standard ISO 14971
* International Medical Device requirements (China, Japan, Canada, Australia, Brazil, Russia, etc.)
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.