manager, management consulting service

bioLytical is hiring an demonstrated Regulatory Affairs (RA) Associate. You will actively support operations for the market entry of new IVD products and the maintenance of licenses for commercially marketed products. You will share your expertise and help train team members. As a RAC certified professional with US FDA experience, you play a vital role in driving forward our mission to get people tested with the best technology on the market, living the Core Values through and through.HOW YOU WILL CONTRIBUTELead the management of regulatory activities involving compliance with government regulations and maintenance of establishment licensesLead regulatory strategy development and analyze design changes requiring regulatory approval before implementation. Appropriate product classification, preparation of regulatory submissions, and effective negotiation of approvals for device applications from WHO, US FDA, Australia, Health Canada, etc., will be conducted.Perform regulatory activities, such as analytical studies and clinical evaluation strategy reviews, to meet necessary regulatory requirements. Responsible for new product application submissions, assessment of post-market changes and surveillance, and labelling reviews.Provide guidance and interpretation of regulatory requirements to responsible teams such as R&D, Clinical Affairs, Marketing, QA/QC, Senior executives and other associates as neededAssist in the management of regulatory compliance activities, including coordination of product recalls and support during audits and inspectionsProvide mentoring and training to team members through the sharing of knowledge, advice and resourcesActs as SME for regulatory tasks during an internal /external audit and lead Regulatory Affairs? CAPAs and improvements stemming from internal/external auditsLead management review meetings and pre-submission meetings with regulators, submit meeting minutes, and engage necessary cross-functional teams in such meetings.WHAT YOU WILL BRINGBachelor?s degree in life sciences/engineering.5+ years of demonstrated Regulatory Affairs experience in the Medical Device/IVD industry.RAC Devices certification will be an asset.Expert professional knowledge of US FDA (510k, De Novo, PMA), Canadian regulations, EU IVDR, and Australian regulations for medical devices and IVD.Experience preparing medical device license applications and change notifications for license amendments. Proficient Communication Skills required to confidently conduct correspondences with regulators. Strong proficiency with Adobe and Microsoft.WHAT WE OFFERA competitive compensation packageExtended health benefits including dental - 100% employer contributionFlexible working hoursPaid sick daysBonus day off with pay on your birthday every year!Full-size in-house fitness gym and shower facilitiesComplimentary reserved parkingOpportunity to work with industry experts who are motivated and passionate about what they do but know how to have some funA chance to show off your dance moves and singing voice at the company parties and jump in to score a victory or lead the way in our outdoor games at the summer barbequesThe opportunity to join an ?off the charts? foodie culture in our large kitchen and try out your favourite recipes or enjoy the culinary delights as they hit the share tableThe annual base salary for this job ranges from:$80,000-$85,000bioLytical's pay range is based on multiple factors including experience, education, job-related skills, and equity within the team or organization. About bioLyticalbioLytical Laboratories Inc. is a privately-owned Canadian company focused on the research, development and commercialization of rapid in-vitro medical diagnostics using its proprietary INSTI® technology platform. bioLytical has won several local and industry awards, including BC Exporter of the Year in 2019 and the Globe and Mail?s Fastest Growing Companies list in 2020. We have b Location Richmond , BC Work location On site Salary $ 30.00 to $ 87.00 HOUR hourly Terms of employment Permanent employment Full time Starts as soon as possible Source CareerBeacon #2495714 Various locations Richmond, BC