Manager, Domestic Regulatory Affairs

Manager, Domestic Regulatory Affairs

Join this rapidly growing Stryker Division in Alameda with a growing product pipeline and be accountable for planning and preparation of US product submissions and the RA function. Establish and implement regulatory strategies with cross-functional teams to assure optimal business goals are met. Ensure compliance with domestic regulatory clearances for products which will include marketing, labeling, and literature review. Work closely with Division HQ on submissions.
•Act as a liaison with FDA regarding submissions on new products and expanded labeling of existing products
•Ensure FDA regulations and applicable standards and changes to these are communicated throughout the organization through company policies, procedures, and training
•Develop regulatory approval strategies to meet business objectives
•Review and approve FDA applications as needed prior to submission
•Ensure that all labeling, marketing literature, and internal policies and procedures are reviewed for compliance to international regulatory requirements
•Ensure that all changes to products and processes (including additions and deletions) are reviewed for compliance to FDA clearances for marketed products. Create new submissions if needed.
•Participate in the preparation of Regulatory Affairs operating plans and objectives in alignment with company and departmental strategies
•Plan and manage key projects to ensure resources and support are provided as needed and report metrics to upper management
•Remain current with new product development projects in order to ensure domestic regulatory requirements are considered and appropriate strategies developed
•Ensure that departmental Standard Operating Procedures (SOPs) are developed, implemented, and maintained
•Review Quality System procedures for domestic regulatory impact
•Prepare and manage budget for the Regulatory Affairs department
•Participate in continuous improvement activity and process re-engineering projects
•Plan and prepare US Product Submissions

Qualifications/Work Experience

•5 years experience in medical device regulatory or quality function
•Demonstrated 510(k), PMA organization, preparation, and review experience
•Understanding of the device listing and establishment registration process
•Experience with communication to FDA including submissions and meetings
•Demonstrated experience in interacting with FDA reviewers/inspectors
•Experience participating in new product development teams, developing regulatory plans and strategies

Education and/or Special Training

Bachelor's Degree in Scientific Discipline or equivalent, Prefer Advanced degree; Prefer Regulatory Affairs Certification