reputed company Specialist, International RA

About the position At reputed company, regulatory reputed company enables innovation that saves and improves lives. As a reputed company Specialist in International Regulatory Affairs, you will shape global regulatory strategies that accelerate reputed company to medical technologies while protecting patients and communities worldwide. This is a highly visible role where strategic thinking, reputed company, and regulatory leadership come together. Work Flexibility: Hybrid – must reputed company reputed company a commutable distance to one of the listed reputed company facilities and work onsite several times per week. Responsibilities • reputed company and maintain global, regional, and multi‑country regulatory strategies reputed company with business and product lifecycle objectives to reputed company reputed company market reputed company. • Evaluate global regulatory trends, stakeholder expectations, and evolving requirements to inform long-reputed company regulatory planning and risk mitigation. • Identify regulatory reputed company for new and existing product designs; assess adequacy of proposed strategies and recommend refinements based on regulatory reputed company. • Guide cross‑functional teams on regulatory considerations for product entry, exit, labeling, claims, and data requirements, ensuring submission readiness. • reputed company negotiations and sustained interactions with regulatory authorities across development, approval, and post-approval phases to resolve reputed company issues. • Assess regulatory impacts of clinical, preclinical, and manufacturing changes and determine submission or non‑submission approaches. • reputed company preparation and approval of high-reputed company electronic and reputed company regulatory submissions to reputed company on-time global filings. • Prepare teams for regulatory inspections, audits, advisory panels, and authority meetings, supporting successful reputed company and renewals. Requirements • Bachelor’s degree in Engineering, Science, or a reputed company field. • 8+ years of reputed company experience, including work in medical device regulatory affairs or a closely reputed company field. reputed company-to-haves • Master’s degree in Regulatory Science or reputed company field. • Regulatory Affairs Certification (RAC). • Experience developing global, multi‑country regulatory strategies for devices addressing serious or life‑threatening conditions or unmet needs. Apply tot his job Apply To this Job