Joseph Novalany

Regulatory Affairs Specialist

Role
Regulatory Affairs Specialist Ii - Crm at Boston Scientific
Location
Minneapolis, MN, US
LinkedIn followers
500 followers

About Joseph Novalany

Regulatory Affairs Specialist with over 3 years of experience in the medical technology sector. Proven track record in navigating complex regulatory environments, ensuring compliance with FDA, EMA, and other global standards. Expertise in managing submissions, conducting regulatory impact assessments, and collaborating cross-functionally to expedite product approvals. Adept at interpreting regulatory requirements and implementing strategic solutions to achieve business objectives.Specialties include: Therapeutic Areas: Organic and Biological Chemistry, Microbiology, and PhysiologyDisciplines: Regulatory Affairs, Clinical, Quality Control and Quality Assurance in Pharmaceutical sciencesRegulatory Agencies: FDA, Health Canada, BSI, TGA Other skills: Project Management, SAP (Logistic modules- SD, MM) and Computer System Validations (CSV)

Experience

  1. Regulatory Affairs Specialist Ii - Crm

    Boston Scientific

    Oct 2024 — Present · Arden Hills, MN, US

Education

  • St. Cloud State University

    Master of Science - MS, Regulatory Affairs & Services

  • University of Minnesota

    Psychology, Bachelor of Science

    2017 — 2021

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Joseph Novalany — Regulatory Affairs Specialist Ii - Crm at Boston Scientific in Minneapolis, MN, US | Unifers