Job Title: Regulatory Affairs Operations Specialist
Duration: 4+months with possible extension
Location: Andover MA
Description of Duties:
• Managing the FDA establishment registrations and device listings process for all Philips facilities. Providing input to management regarding Philips-wide establishment registration strategy.
• Managing the medical device manufacturer/distributor US state licensing process for Philips facilities.
• Owning the FDA Certificates to Foreign Government and embassy authentication submission strategy and execution for all Philips businesses.
• Owning and maintaining the regulatory deliverables database across all Philips businesses, creating a central location for regulatory teams and distributors to access regulatory documents and certificates for worldwide product registrations and approvals.
• Owning and maintaining department procedures related to the above responsibilities
• Notarizing regulatory documents.
Education & Training:
• Bachelor’s degree in a related technical or business discipline.
• A minimum of 3 years related experience in the medical device industry.
• 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 desirable.
• Familiarity with managing Microsoft SharePoint sites.
• Demonstrated ability to effectively interact with employees and managers on all levels.
• Goal-oriented and proactive in problem solving.
• Strong written and verbal communication skills.
• Attention to detail.
• Must be able to perform responsibilities with minimal supervision.
Thanks and Regards,
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560