Associate Director, Regulatory Affairs (on-site)

About the role

At Abbott, we are a global healthcare leader that creates breakthrough science to improve people’s health. We are dedicated to helping people manage their health with life-changing products and services, and we are constantly innovating in the field of digital health technology.

Responsibilities

• Develop global regulatory strategies for product development and planning throughout the product lifecycle.
• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
• Provide technical leadership and strategic input on complex issues and to business units.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Create project plans and timelines.
• Lead functional groups in the development of relevant data to complete a regulatory submission.
• Write and edit technical documents.
• Recruit, develop and manage regulatory professionals.
• Evaluate performance of and assist in career development planning for subordinates.
• Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
• Negotiate with regulatory authorities during the development and review process to ensure submission approval.
• Review and approve labeling to ensure compliance.
• Monitor emerging issues and identify solutions.
• Negotiate internally and externally with regulatory agencies.
• Identify need for new regulatory policies, processes and SOPs and approve them.
• Evaluate regulatory risks of corporate policies.
• Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
• Ensure compliance with product post-marketing approval requirements.
• Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events.
• Actively contribute to the development and functioning of the crisis/issue management program.
• Analyze product-associated problems and develop proposals for solutions.
• Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.
• Provide regulatory input for product recalls and recall communications.

Requirements

• Bachelor's degree
• 5-7 years’ experience in a regulated industry (e.g., medical products).
• 5-7 years’ 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.

Preferred Qualifications

• Bachelor's degree in computer science, math, engineering, or medical fields.
• M.S. in a technical area or M.B.A. is preferred.
• A Ph.D. in a technical area or law is helpful.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.).
• Experience with Class III US and EU submissions and Software as a Medical Device (SaMD).
• Experience with FDA QSR and EU MDR and interfacing directly with regulatory authorities.
• 7-10 years’ experience in a regulated industry.
• Regulatory area is preferred but may consider software or systems research and development, or related area.

Benefits

At Abbott, we offer comprehensive benefits including:

• 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.

Pay

The base pay for this position is $148,700.00 – $297,300.00. In specific locations, the pay range may vary from the range posted.