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Director of regulatory affairs

This is a Full-time position in Laguna Hills, CA posted December 18, 2019.

Director of Regulatory Affairs serves as liaison between the company and government agencies to achieve marketing authorizations for Sonendo products.

Collaborates with R&D and Marketing leaders to determine regulatory strategies for new products, changed products, and product launches in new regions.

Essential Duties and Responsibilities:
· Determine submission strategies and timing for new products, changed products and new markets.
· Maintain registrations, listings, licensing, and distribution authorizations for products sold in US and OUS.
· Serve as UDI regulatory contact.
· Review and collect scientific data.
· Prepare and submit regulatory filings (Technical Files, 510(k)s, CFDA Summaries, etc.) as required to meet product introduction timelines.
· Collaborate with R&D project leaders to identify regulatory strategy from product inception to launch.
· Manage product technical file updates (US and OUS) as necessary.
· Implement requirements for serious adverse event reporting in US and OUS markets.

· Review complaints to determine reportability of serious adverse events and submit adverse event reports as to agencies as necessary.
· Supervise Regulatory Affairs Manager and/or Regulatory Affairs Specialist as required.
· Review and determine impact of changes to worldwide regulations.
· Provide sufficient and qualified representation for Sonendo as designated representative incharge.
· Perform related duties as assigned by supervisor
· Maintain compliance with Quality System procedures and company policies Education and/or Work Experience Requirements:
· Excellent verbal and written communication skills, including ability to effectively communicate at all levels of the organization and with government agencies.
· Strong awareness of technical standards and regulatory requirements related to Sonendo’s devices.
· Outstanding analytical and decision-making skills.
· Good computer proficiency (Word, Excel, Outlook, PDF files) and proficiency at managing large documents (indexing, page numbering, editing > 50KB).
· Thorough working knowledge of FDA 21CFR820, ISO 13485, ISO 14971, MDSAP, MDR, GUDID, GMDN, GTIN.
· Capable of working under pressure while maintaining a positive attitude and meeting predetermined deadlines.
· Bachelor’s degree in a science field with a minimum of 12 years related industry experience required.

Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk and sit for extended periods of time. Occasionally the employee will be required to lift or move at least 50 pounds.

Employee must be able to talk, listen and speak clearly on telephone and/or VOIP.