Senior Regulatory Affairs Specialist – Vascular

Role Overview

• Provide regulatory input to product lifecycle planning.
• Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
• Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval.
• Determine and communicate submission and approval requirements.
• Participate in risk-benefit analysis for regulatory compliance.
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
• Compile, prepare, review and submit regulatory submissions to authorities.
• Monitor impact of changing regulations on submission strategies.
• Monitor applications under regulatory review.
• Monitor and submit applicable reports to regulatory authorities.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
• Maintain annual licenses, registrations, and listings.
• Assist in compliance with product post-marketing approval requirements.
• Assess external communications relative to regulations.
• Assist with labeling development and review for compliance before release.
• Support change management process to assess regulatory impact of change and consequent submission requirements.
• Analyze the impact of cumulative product changes to current product submissions.
• Participate in compliance activities by providing regulatory input for non-conforming products, field actions, and CAPA.
• Assist in site audits conducted by internal and external auditing bodies.

Requirements

• Bachelor's Degree in a related field OR an equivalent combination of education and work experience
• 3-4 years of experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.
• 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.
• Strong organizational and follow-up skills, as well as attention to detail.
• Organize and track complex information.
• Exercise good and ethical judgment within policy and regulations
• Use in-depth knowledge of business functions and cross group dependencies/relationships.
• Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.

Benefits

• Career development with an international company where you can grow the career you dream of
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit
• an affordable and convenient path to getting a bachelor’s degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists