Global Regulatory Affairs Director
Sterling Life Sciences - Los Angeles, CA

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1) Manage the process from development of regulatory strategies through to approval
2) Prepare and submit domestic and international submissions and ensure compliance with all US and International regulatory requirements pertaining to product approval
3) Ensure rapid and timely approval of devices and act as a direct liaison with regulatory authorities
4) Prepare US and International regulatory submissions, including but not limited to 510(k) submissions, pre and post marketing surveillance activities, technical files, health Canada licenses and change notices
5) Interpret existing or new regulatory requirements as they relate to company products and procedures, clinical studies, testing, records, etc.
6) Provide regulatory guidance and support to project teams, including regulatory filing strategies, testing and standards requirements
7) Review, analyze and approve technical data generated by Research and Development, Manufacturing, Marketing, Quality Assurance or other related departments for filing purposes
8) Review, provide feedback and approve design and manufacturing changes, nonconforming materials reports, test protocols and reports to ensure regulatory compliance with FDA, Health Canada, MDD, JPAL, ISO 9001, ISO 13485 and applicable standards and determine filing or notification requirements
9) Advise on international product registration and export approval requirements, obtain Certificates to Foreign Government (CFG's) as required
10) Provide input, review and necessary approval of promotional and advertising materials, product claims, training materials, instructions for use, technique manuals, labeling and other related documentation to ensure compliance with regulations
11) Manage complaints and lead vigilance, MDR reporting efforts, market withdrawals and serve as the recall coordinator
12) Provide update on regulatory requirement changes, which affect individual product specification or quality systems
13) Work closely with Quality Assurance and participate in the conduction of internal audits and hosting of external audits as well as communicate with Regulatory officials, as required
14) Maintain technical files and product schedules for CE marked products and make submittals and communications to the notified body
15) Work closely with R&D/Engineering in the implementation of design control projects
16) Establish appropriate risk analysis activities which include the use of risk analysis tools such as FMEA and risk analysis testing to understand and mitigate risk
17) Continue to improve the process of leveraging regulatory as a source of competitive advantage by improving speed to market, establishing precedence for novel regulatory approaches and obtaining unique claims
18) Manage consultant agreements and workloads
19) Cultivate professional relationships with Health Authorities and other outside contacts
20) Establish solutions to regulatory problems utilizing novel approaches when required
21) Ensure that all regulatory related policies and procedures are current in accordance to applicable regulations and standards and that regulatory staff is appropriately trained
22) Align domestic and international submissions based on product launch timelines

1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people who have recent experience in Regulatory Affairs Management

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