Regulatory Affairs Manager - Electrophysiology (on-site)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

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. You’ll 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 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.

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

The Opportunity

The Regulatory Affairs Manager will work on-site at our Plymouth, MN location for our Electrophysiology division. As a manager, the function of a Manager Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. This new team member will develop and supervise regulatory professionals as well as share knowledge and expertise with others in support of team activities. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. This Regulatory Affairs Manager may analyze broad scope implications of changing regulations and guidance. Additionally, may identify data needed, obtain this data, and ensure that they are effectively presented for the registration of products worldwide.

What You’ll Work On

• Develop new regulatory policies, processes and SOPs and train key personnel on them.  Evaluate regulatory risks of division policies, processes, procedures. Recruit, develop and manage regulatory professionals.
• Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management. Provide strategic input and technical guidance on regulatory requirements to development teams.
• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes.
• Assist in regulatory due diligence for potential and new acquisitions.
• Utilize technical regulatory skills to propose strategies on complex issues. Determine submission and approval requirements. Identify emerging issues.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Monitor trade association positions for impact on company products.
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities.
• Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions.
• Monitor impact of changing regulations on submission strategies and update internal stakeholders. Monitor applications under regulatory review. Communicate application progress to internal stakeholders. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
• Negotiate and interact with re