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. • TheSenior 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 REQUIREDBenefits:• 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 benefits Apply tot his job