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Regulatory Affairs Associate (574320)

Company:
Placement Services USA, Inc.
Location:
Redwood City, California, United States
Salary:
Not provided
Posted:
April 16, 2019

Posted By Premium Recruiter

Description:

Job duties - Work on the regulatory submission preparations, document filings and communication with all government agencies responsible for regulating company products. Research and summarize international and domestic regulations that affect our business, document articles, and communicate internally to ensure compliance with such rules and regulations. Assist in the development of regional regulatory strategy. Monitor impact of changing regulations on submission strategies. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. Work on device filing and combination product filing. Draft Product Information, Consumer Information, literature searches to support submissions. Monitor applications under regulatory review. Assess product changes to capture any impact to existing or in-process product registrations and letters to file for US and EU. Submit and review change controls to determine the level of change and consequent submission requirements. Lead labeling/UDI (unique device identification) compliance activities. Assist with label development and review for compliance before release. Attend local meetings/conferences where regulatory team contribution is essential (requiring travel of approximately 4-8 hours/year). Contribute to the development of procedures to ensure regulatory compliance.

Education and Experience - Bachelor’s in one of the life sciences fields of study plus 5 years of regulatory affairs experience in medical device or pharmaceutical industry; OR Master’s in one of the life sciences fields of study plus 3 years of regulatory affairs experience in medical device or pharmaceutical industry.

Background - Knowledge of labeling and UDI regulations. Knowledge of medical device regulations. Knowledge of pharmaceutical and combination product regulation. Knowledge of ISO standards 9001, 10993, 13485, and 14971. Knowledge of 510(k) IND NDA submissions in the U.S., and CE Marking MAA submissions in the E.U. Analytical, multi-tasking, and organizational skills with attention to detail; background communicating and working in a diverse team environment with effective interactions with technical personnel, as demonstrated by having led at least one submission (or assisted with 3 submissions), and represented a regulatory group in a cross-functional team meeting.

Please copy and paste your resume in the email body do not send attachments, we cannot open them and email them at candidates at placementservicesusa.com with reference #574320 in the subject line.

Thank you.