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Experis IT ManpowerGroup has partnered with a leading Medical device organization in the Santa Clara, CA for a Regulatory Affairs Manager role to assist their team. This is an on-site role.

Industry: Medical device

Title: Regulatory Affairs Manager

Pay Rate: $50-56/hr on W2

Location: Santa Clara, CA

Duration: 9 months contract with possible extension or hiring

Job Description :

Regulatory Affairs Project Manager (Individual Contributor Role)

This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs.

Provides regulatory affairs project management for various areas, to include regulatory submissions for new products, label/advertising/promotional review, and other regulatory compliance activities. In collaboration with Regulatory leadership, develops and implements regulatory strategies that will ensure earliest possible introduction of new product(s) into domestic and international markets.

For this position it will be necessary to bring:

• Bachelor's degree (preferably in medical, science or engineering related discipline) or equivalent combination of education and work experience.

• Preferably 8 years experience in the medical device industry, with 5 of those years related to the preparation of FDA and EU MDR submissions for Class III medical devices.

• Ability to work effectively on project teams. Ability to leverage and/or engage others to accomplish projects

• Must be able to juggle multiple and competing priorities.

• Strong written, verbal, presentation, and organizational skills.

• Working knowledge of QSR, ISO, and EN standards.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.