Combination biologics company in LA is looking for a new Regulatory Affairs Specialist to assist with global and domestic submissions. This role would be working on both pre-market and post-market regulatory work as they are currently selling internationally in the APAC and EU regions and in the middle of launching domestically. This Regulatory Affairs Specialist will be a direct hire role and a part of a growing start up team of about 20. They recently received an $8Mil grant from the US government to launch their products nationwide in hospitals and they need assistance for their PMA submission- making this role a critical hire before December. Interviews with the top candidates will be conducted by the Senior Director on Wednesday the 2nd so it is a bit time sensitive that if you are interested so please apply below.
Assists in interpreting and applying FDA regulations to business practices, evaluating risk and proposing solutions to regulatory strategies.
Will aid with interactions with regulatory agencies including responses to regulatory inspections, regulatory submissions, responses to regulatory submissions, and meetings with regulatory agencies.
Help to ensure that all contracts between the company and its clients are properly reviewed for regulatory coherence and are amended when necessary to assure that the appropriate regulations are cited and the level of compliance is attainable by both parties.
Assist in reviewing proposed labeling for compliance with applicable US and international regulations
Support international regulations; maintain technical files and internal licenses.
Regulatory Affairs background in the Medical Device industry.
Knowledge of FDA regulations (including labeling regulations) and global regulations.
Must possess a successful track-record of assisting with U.S. and international regulatory agencies to meet high regulatory compliance standards.
Working knowledge of FDA, CFR Title 21, Part 820, IEC60601 and ISO 13485
3+ years regulatory experience in the medical device industry
Experience with Pre-Market Approval (PMA) a strong bonus
Must have strong English written and verbal communication skills, and have experience working on cross functional project
Strong ability to problem solve and apply analytical thinking is required.