- Title: Regulatory Affairs Associate
- Code: RCI-5467
- Location: Santa Clara California (CA) 95054
- Posted Date: 09/29/2020
- Duration: 12 Months
- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
West Coast based (Remote, but near Temecula, Santa Clara, Sylmar or Minnesota, Pacific Time Zone shift)
Regulatory Affairs Associate - Regulatory Operations
1 year assignment
Hours Monday-Friday • 8am-5pm
- Site is Santa Clara Responsibilities: Execution of global product release authorizations following verification of regulatory approval and commercial alignment in activities.
- Minimum 2 years’ Experience
- Daily support of product releases allowing shipment of product to achieve departmental and organizational objectives.
- Have a full working knowledge of the product release process including country regulatory and language requirements.
- Provide support for Product and Country Experts in the set-up for release of new and modified products globally.
- Acts as a regulatory representative for review and analysis of product release challenges, providing guidance and direction on regulatory compliance.
- Review and evaluates customer service requests, maintaining a high level of service and follow through on all communications.
- Systems knowledge such as SAP and Windchill is an advantage for creating releases
Ability to work independently