Medical Device, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
The Senior Regulatory Affairs Consultant is responsible for authoring and managing submission process for IND’s, NDA/ANDA’s, 510k’s, and PMA’s for a medical device company in the Bay Area.
Prepare US, EU, and international submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release.
Review complex product submissions with manager or other senior management and negotiate submission issues with agency personnel. All significant issues will be reviewed with the manager and/or other senior management.
Prepare regulatory strategies/plans and worldwide requirement lists. Provide leadership to product development teams for regulatory issues and questions.
Provide business and product information to international regulatory managers to enable development of worldwide strategies and requirements, and communicate that information to business teams. Provide product and test information to major markets to support their local regulatory submissions.
Provide support to market-released products as necessary. This includes reviewing labeling, promotional material, product/manufacturing process changes and documentation for changes requiring regulatory approval.
Prepare submissions and reports for FDA and support other major market regulatory agencies as required by product status.
Develop proficiency in worldwide regulatory requirements and establish and maintain good working relationships with agency personnel
Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
Must have 5-10 years of medical device experience in regulatory affairs.
Must have class II & III medical device experience.
Must be local to the Bay Area, if not open to travel to the client site during normal business hours..
Experience in filing PMA’s, IND’s, NDA’s/ANDA’s, and/or 510k’s.
Excellent organizational skills
Must be proficient in Microsoft Office Suite
Internal Number: 1
About Delta Project Management
Delta Project Management was founded in 2006 with the vision of becoming the leading provider of Regulatory Compliance and Project Management solutions for every major Life Sciences market nationwide.
We pride ourselves on the quality of service to our clients, the professional excellence of our staff, and our reputation for delivering project success.