Job Title: Sr. Program Manager, Regulatory Affairs Operations
Duration: 3+months with possible extension
Providing leadership & strategic compliance direction to the global regulatory organizations throughout Philips.
Continuously maintaining market insight into the evolving worldwide regulatory compliance issues, and assessing impact and risk on existing Philips processes and shipment impediments to Philips products.
Owning Philips-wide strategy and execution for:
FDA establishment registration and device listing;
Medical device, food and cosmetic manufacturer/distributor/retailer US state licensing;
FDA Certificate to Foreign Government and embassy authentication;
InCenter regulatory deliverables database, a central location for regulatory teams and distributors to access regulatory documents and certificates for worldwide product registrations and approvals.
Education & Training:
Bachelor’s degree in a related technical or business discipline.
A minimum of 6 years related experience in the medical device industry.
Excellent working knowledge of FDA medical device regulations. Experience with FDA establishment registration, medical device manufacturer/distributor US state licensing and/or Certificate to Foreign Government applications highly desirable.
Demonstrated ability to effectively interact with employees and managers on all levels.
Goal-oriented and proactive in problem solving.
Excellent interpersonal communication skills (written and verbal).
Ability to manage and prioritize multiple projects.
Strong organizational skills and attention to detail.
Please send me your confirmation that no one else has contacted you for this position apart from APN Team.
Thanks and Regards,
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560
Direct: 510.870.8798 | Fax: 510.623.5055 | firstname.lastname@example.org