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

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and family be your true self and live a full life. Youll also have access to:

• 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 bachelors 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

Structural Heart Business Mission: why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

This individual contributor role is based on-site at our St. Paul/New Brighton MN facility within Abbotts 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.

WHAT YOULL DO

• 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

Required Qualifications

• Bachelors 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.

Preferred Qualifications

• Bachelors 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
• Uses in-depth knowledge of business functions and cross group dependencies/ relationships

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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