manager, legal firm

bioLytical is hiring an experienced Regulatory Affairs (RA) Manager. You will be responsible for defining and implementing regulatory strategies to obtain global approvals for new/modified devices to meet bioLytical?s corporate objectives. This role requires the ability to analyze complex technical and medical information and formulate strong regulatory arguments that can be defended with regulatory agencies such as US FDA, Health Canada and international Health Authorities. The Regulatory Affairs Manager is responsible for all product licensing and registration, medical device reporting, reviewing customer complaints, post-market surveillance, product labeling, and permissible marketing communication. HOW YOU WILL CONTRIBUTEWorking closely with Executive Management, Sales and Marketing and Scientific Affairs to develop the regulatory strategy to gain market approval for new or modified devices consistent with corporate objectivesLeading the preparation of complex submissions including PMAs, 510(k)s, PMA Supplements, Design Dossiers (CE), Change notifications, Health Canada license applications and amendments, Renewals and Annual Reports, WHO prequalification submissions and change notifications. All other regulatory submissions to concerned International Competent AuthoritiesConducting/overseeing regulatory assessments for all document, product, and process changes to ensure that change notifications to regulatory bodies are appropriately submittedConducting/overseeing medical device event reporting and complaint handling in accordance with regulations along with post-market surveillance activities Participating in designing, reviewing and approving product support internal studies and clinical evaluationsEnsuring product labeling and promotional materials are compliant with regulationsEnsuring all national registrations, licenses, listing, and other certifications are maintained as required for regulatory complianceMaintaining a good working relationship by interacting proactively and persuasively with global regulatory agencies to gain approvalsGuiding product development teams in developing new products compliant with Design Control regulations for each applicable regulatory jurisdictionParticipate in risk assessment of the device and usability Ensuring clinical studies are designed and executed in full compliance to GCP, ICH, and pertinent global regulationsEnsuring the promotion of awareness of regulatory requirements throughout the organizationStay up-to-date with regulatory requirements for US FDA, Health Canada, European CE marking, World Health Organization, Australia Therapeutic Goods Administration, and rest of the world (as applicable). Actively review new regulatory requirements to maintain proficiency in worldwide regulations and communicate pertinent information.Responsible for developing and meeting regulatory timelines and budgetsWHAT YOU WILL BRINGBachelor or Master?s degree in a scientific or engineering discipline, or equivalent combination of education and experienceA minimum of 5 years of work experience in medical device/IVD compliance and regulatoryIn-depth knowledge of Canadian, US and European regulations, ISO 13485 and ISO 14971Regulatory Affairs Certification strongly preferredStrategic leadership, strong communication and persuasion skills, and the ability to craft strong regulatory argumentsSuperior analytical, problem solving and reviewing skills Must be able to deliver results on schedule in a fast-paced, dynamic environmentExcellent prioritization, organizational and project management skillsEffective written & verbal communication and technical documentation skillsExcellent computer skills (MS Office, Access, Excel) Able to operate independently with minimal directionExcellent interpersonal skillsFlexible and adaptable to take on additional responsibilities as appropriateWHAT WE OFFERA competitive compensation packageExtended health benefits includi 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 #2495669 Various locations Richmond, BC