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LSK Technologies Inc.: Regulatory Affairs Specialist

LSK Technologies Inc.

This is a Full-time position in Mapleton, ON posted February 3, 2021.

Job DescriptionWho We Are: Are 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 todays 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 todays 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) requirementManagement of communications with regulatory agencies and external partners managing regulatory submissions on behalf of the organizationProviding 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 registrationsParticipating in opportunities to develop regulatory and medical device business knowledgeReview of marketing material to determine alignment with regulated product claimsSupporting quality management system and compliance activities as needed (e.G.

change control, audits)RequirementsSuccessfully candidate will have:Required:Regulatory affairs diploma or education in progress from an accredited collegeUnderstanding of collecting evidence of Good Manufacturing Practices and Quality management system (QMS)Understanding of the establishment Manufacturers QMS based on ISO 13485Understanding 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 skillsGood with problem-solving.

Work productively.

Bonus:Experience with IEC 62304Experience with risk management related to ISO 14971 and CLISIExperience 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 experienceWork experience with designing and testing a medical deviceBenefitsTBD based on skillset.