Regulatory Affairs Manager - International Compliance Operations – Structural Heart (on-site)

Abbott • Saint Paul, MN

2d • Onsite

About The Position

This individual contributor role is based on-site at our St. Paul/New Brighton, MN facility within Abbott’s Structural Heart Division. The candidate will leverage expertise in scientific, regulatory, and business considerations to ensure products developed, manufactured, or distributed comply with all applicable regulations. This team member will support multiple product lines and therapies, serving as a recognized subject-matter expert and mentor within the department.

Requirements

• 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.
• Note: Higher education may compensate for years of experience.
• 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.

Nice To Haves

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
• Previous experience with US (e.g. PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions
• Experience with Class II and Class III medical devices
• 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
• Experience with exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Has broad knowledge of various technical alternatives and their potential impact on the business

Responsibilities

• 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 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 review process to ensure submission approval
• Ensure compliance with US and global product post marketing approval requirements
• Evaluate proposed preclinical, 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager