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regulatory affairs associate
Title posted on indeed.com - Associate II, Regulatory Affairs
Posted on November 12, 2024 by Employer details bioLytical
Job details
*bioLytical* is hiring an experienced Regulatory Affairs (RA) Associate. You are responsible for executing regulatory tasks related to obtaining approvals for new or modified products and maintaining existing product registrations to meet bioLytical?s corporate objectives. You will 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 CONTRIBUTE* - Prepare complex submissions including change notifications, amendments and initial applications to US FDA, Health Canada, Notified Body, WHO. These include PMA supplements, 510(k)s, new PMAs, Health Canada MDLs, Notified Body/Competent Authorities. - Lead regulatory activities related to product registrations in Rest-of-the-World markets, including but not limited to the WHO and countries in Asia, Africa, and Latin America. This includes creating/revising regulatory submissions in desired formats, facilitating document authentication/legalization, providing routine project updates, and liaising with ROW business partners as needed. - Draft regulatory strategies for any new products for approvals in major markets. - Assess customer complaints for regulatory reporting of adverse events and report any MDRs as required. - Review and provide input into marketing/sales materials to ensure compliance with the governing regulations and company procedures. - Prepare annual reports and renewal submissions to various regulatory jurisdictions and obtain successful approvals. - Actively review new external standards/regulations updates globally and communicate pertinent information to responsible teams. - Maintain a good working relationship by interacting proactively and persuasively with global regulatory agencies to gain approvals. - Schedule Q-sub/Pre-sub meetings with regulatory agencies and coordinate internal teams. - Participate in the Internal Audit program and External certification audits at bioLytical Laboratories as a key contributor. *WHAT YOU WILL BRING* - Bachelor?s degree in life sciences/engineering. - Minimum 3+ years of Regulatory Affairs experience in the Medical Device/IVD industry. - Medical Device Regulatory certifications (RAC -Devices) will be an asset. - Professional knowledge of US FDA, 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. - Attention to detail and ability to analyze complex information. - Strong proficiency with MS Office suite and Adobe Professional. *WHAT WE OFFER* - A competitive compensation package - Extended health benefits including dental - 100% employer contribution - Flexible working hours - Paid sick days - Bonus day off with pay on your birthday every year! - Full-size in-house fitness gym and shower facilities - Complimentary reserved parking - Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun - A 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 barbeques - The 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 table The annual base salary for this job ranges from: $60,000-$65,000 bioLytical's pay range is based on multiple factors including experience, education, job-related skills, and equity within the team or organization. *About bioLytical* bioLytical 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 platf- LocationRichmond, BC
- Workplace information On site
- SalaryNot available
- Terms of employment Full time
- Starts as soon as possible
- vacancies 1 vacancy
- Source indeed.com #9524724239
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