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LSK Technologies Inc.: Regulatory Affairs Specialist

LSK Technologies Inc.

This is a Full-time position in Kitchener, ON posted February 25, 2021.

Who We AreAre you passionate about building a better world around you?

Do you feel frustrated with this unprecedented pandemic and wonder how you could contribute to making a positive impact in today’s world?

We are working on it!LSK Technologies (www.Lifesci-key.Com) aims to decentralize diagnostic labs.

We provide easy-to-use and affordable diagnostic tests at the point of sample collection for diagnosing the infection and checking immunity against COVID-19.We are a young startup with a small, fast-moving, and efficient team, based in Velocity Incubator, Kitchener, Ontario.

We are looking for a talented and experienced Regulatory Affairs Specialist to join our team.

With your hard work, we can change today’s world by eliminating the backlog and delays experienced in COVID-19 testing.About The Role Compilation of documents and prepare medical device regulatory applications for submission according to QSR (Quality System Regulations) requirement Management of communications with regulatory agencies and external partners managing regulatory submissions on behalf of the organization Providing regulatory reviews of product design, product changes, and quality management system documentation (including policies, procedures, documents, and records) Providing regular reports to management on the status of regulatory submissions, licenses/clearances, and registrations Participating in opportunities to develop regulatory and medical device business knowledge Review of marketing material to determine alignment with regulated product claims Supporting quality management system and compliance activities as needed (e.G.

change control, audits) RequirementsSuccessfully candidate will haveRequired Regulatory affairs diploma or education in progress from an accredited college Understanding of collecting evidence of Good Manufacturing Practices and Quality management system (QMS) Understanding of the establishment Manufacturer’s QMS based on ISO 13485 Understanding of the EU IVDR and CE mark (98/79/EC), and FDA EUA Experience with compiling Technical File and draft instructions of use Strong communication and collaborative skills Good with problem-solving.

Work productively.

Bonus Experience with IEC 62304 Experience with risk management related to ISO 14971 and CLISI Experience with CLIA Experience with data protection regulation and law US Health Insurance Portability and Accountability Act (HIPAA) or/and Personal Information Protection and Electronic Documents Act (PIPEDA) or/and General Data Protection Regulation (GDPR) 1+ years of industry experience Work experience with designing and testing a medical device BenefitsTBD based on skillset.