Regulatory Affairs Manager – Vascular (on-site)

• 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

• 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

• Provide regulatory input to product lifecycle planning. Provide strategic input and technical guidance on regulatory requirements to development and manufacturing teams
• Prepare robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectives
• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
• Support pre and post approval clinical strategy and submission activities
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
• Assess the acceptability of development, quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submissions to authorities
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
• Ensure compliance with US and global product post marketing approval requirements
• Evaluate proposed clinical and manufacturing changes for regulatory filing strategies
• Execute and manage technical and scientific regulatory activities. Must function independently as a decisionmaker on regulatory issues and must assure that deadlines are met
• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements.
• Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units
• Provide leadership and guidance towards achieving department objectives and act as a mentor to less-experienced staff
• May lead a cross-functional or cross-divisional project team
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures

• Bachelor's Degree in a related field OR an equivalent combination of education and work experience
• Minimum 4 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.
• Domestic and international regulatory guidelines, policies and regulations.
• Lead functional groups in the development of relevant data to complete a regulatory submission.

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
• Master’s or Ph.D. in a technical area
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Previous experience with PMA / IDE and international submissions
• Experience with combination product and/or Class III medical devices
• Experience with IDE trial strategy and post market clinical activities
• Ability to define regulatory strategy. Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Experience with post-approval manufacturing and design changes
• Ability to work effectively on cross-functional teams
• Strong attention to detail
• Experience with organizing and tracking complex information. Able to juggle multiple and competing priorities
• Uses in-depth knowledge of business functions and cross group dependencies/ relationships

Abbott