Project Manager, Regulatory Affairs - 26153BR - EN in Fremont, CA at Stryker Corporation

Date Posted: 6/11/2018

Job Snapshot

Job Description

Who we want

Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues.
Focus. Takes direction, follows through, and makes the corrections necessary to stay on track. Prioritizes then acts.
Achievers. Thrives on accomplishing tasks and constantly driven to do more.
Collaborators. Collaborates and builds relationships with internal and external stakeholders.
Communicators. Articulates well and expresses ideas effectively.
Learners. Great desire to learn and looks to continuously improve.
Teammates. Supports, encourages, and inspires others.

What you will do

The Project Manager, Regulatory Affairs provides leadership, organization and coordination of the Neurovascular global regulatory strategies and submissions required to support high impact product launches and ongoing market access . This critical function assures that the company’s strategic plan for its new and sustaining product portfolio is developed, implemented, and maintained globally on a pre-market and post-market basis. Additionally, the Project Manager, Regulatory Affairs will work with project teams and management to execute the strategic plan.
•Opportunity to manage global cross-functional projects on innovative neurovascular technologies that are US/EU Class III and US Class II with IDE clinical studies.
•Partner with organizational, program, and project management to drive the strategy for product portfolio growth
•Provide regulatory guidance and strategic direction to accelerate product development and process improvements involving high risk combination products.

Job Requirements

What you need
•Bachelor degree required; advanced degree or commensurate work experience preferred
•7+ years’ experience in an FDA regulated medical device environment
•2+ years’ demonstrated project management experience in at least one discipline (RA, R&D, Operations, PMO, etc.).
•Excellent interpersonal communication, collaborative team work, and negotiation skills
•Demonstrated ability to plan and conduct meetings
•Demonstrated experience presenting to management and ability to build trusting relationships
•Knowledge of the Quality System Regulations (21 CFR) and Medical Device Directives (MDD) and other regulations related to Pre Market Clearance/Approval
•Demonstrated ability to comply with constantly changing procedures and prioritize work effectively.
•Ability to generate and explain detailed proposals, schedules, financial data, objectives, and other documentation accurately.
•Ability to rapidly build product knowledge and understanding of highly technical and scientific regulatory activitiesGood time and project management skills with the ability to multi-task
Strong leadership skills

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