Regulatory Affairs Specialist

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 109,000 colleagues serve people in more than 160 countries.

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That's why we're focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

Our production location in Buffalo Grove, IL currently has an excellent opportunity for a qualified Regulatory Affairs Specialist. This RA Specialist position at Abbott Diabetes Care (ADC) will focus on manufacturing capacity expansion projects for our FreeStyle Libre product family from a regulatory affairs perspective. Reviewing manufacturing validation documentations and change management experience is crucial.

Position Summary

As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. In turn, this incumbent will be able to learn and develop their skills and knowledge related to Regulatory Affairs operations, policies, strategies and requirements. This role may execute tasks and play a consultative role by partnering across business functions, contract manufacturers, and suppliers. The role also assists by researching and identifying data needed, then sourcing / obtaining this information, and then ensuring that the data is effectively presented for the registration of products worldwide. This person may prepare and submit documentation needed for registration worldwide, or may oversee such preparation. This is a broad scoped position with strong opportunity for growth and career development.

Main Responsibilities
  • Provide support for the regulatory department to ensure efficient and compliant business processes and environment
  • Prioritize and manage multiple requests with minimal supervision
  • Execute tasks and play a consultative role by partnering across business functions, contract manufacturers, and suppliers.
  • Review, provide feedback and approve process validation and design transfer documents
  • Research and identify data needed, obtaining this data and ensuring that it is effectively presented for the registration of products worldwide
  • May prepare or oversee such preparation of documentation needed for compliant production registration
  • Assist in SOP development and review,assist in the development of regional regulatory strategy (i.e. the strategic planning process)
  • Provide regulatory input to product lifecycle planning
  • Continue to evaluate and compare regulatory outcomes with initial product concepts to make recommendations on future actions
  • Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval
  • Determine trade issues to anticipate regulatory obstacles
  • Determine and communicate submission and approval requirements
  • Participate in risk benefit analysis for regulatory compliance
  • Assess the acceptability of quality, preclinical and clinical documentation for submission filing
  • Compile, prepare, review and submit regulatory submission to authorities
  • Monitor impact of changing regulations on submission strategies
  • Monitor applications under regulatory review
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
  • Assist compliance with product post marketing approval requirements
  • Review regulatory aspects of contracts
  • Assist with label development and review for compliance before release
  • Submit and review change controls to determine the level of change and consequent submission requirements
  • Provide regulatory input for product recalls and recall communications


EDUCATION AND EXPERIENCE YOU'LL BRING
  • Minimum of two (2) years of experience in a regulated industry (such as Medical Device, Pharma, Nutritionals) is required.
  • Bachelors degree (or equivalent combination of Education and Work Experience) is required.
  • Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
  • Willingness to learn and/or Knowledge of the following is preferred: Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs, GMPs); Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process.


WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:
  • A fast-paced work environment where your contribution is essential to success
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities


Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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