Senior Regulatory Affairs Specialist, IVD supporting US/Health Canada

Job Description: • Responsible for directing activities related to our in-vitro diagnostic products to ensure compliance with local regulations within North America (US and Canada). • Will initiate, develop and implement all phases of regulatory strategy to ensure necessary approvals for company products/services. • Provides regulatory authorities with appropriate documentation in the aim of obtaining licenses and regulations. • Establishes and maintains relationships with external partners, regulators and opinion formers. • Responsible for following regulatory activities at local level. • The Senior Regulatory Affairs Specialist responsibilities encompass to work with corporate RA, R&D, Marketing, Legal, Business Leader and any other relevant department to compile technical information for supporting regulatory submissions for the countries of the region. • Compile appropriate technical documents and author local regulatory submissions for FDA and Health Canada. • Provide guidance to product development teams regarding specific local product submission requirements. • Review proposed labeling changes to determine regulatory impact on existing certifications and registrations. • Work with RA staff, clinical staff and program managers to develop regulatory approval strategies for products and project prioritization. • Conduct training programs to educate employees on regulatory requirements and good regulatory practices. • Review new regulatory guidance and participate in the implementation of programs to support compliance. • Communicate with customers to respond to regulatory concerns/questions. • Maintain product registration data base for North American countries. • May manage communication about vigilance issues for US and Canada. • May lead and direct the work of others. Requirements: • Bachelors Degree required, preferably in STEM/Medicine/Life Science • Masters Degree in Regulatory Affairs preferred • 2+ years of Regulatory Affairs experience with a focus on IVD industry REQUIRED Benefits: • 401(k) with up to a 6% employer match • no vesting period • employee stock purchase plan • flexible time off for salaried employees • accrual of three to five weeks’ vacation annually (based on tenure) • accrual of up to 64 hours (annually) of paid sick time • paid and/or floating holidays • parental leave • short- and long-term disability insurance • tuition reimbursement • health and welfare benefitsApply Now

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