Senior 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.

***Position is based at our manufacturing facility in Buffalo Grove, IL.***

This new Senior RA Specialist position at ADC will focus on manufacturing capacity expansion projects for our FreeStyle Libre product family from a regulatory affairs perspective. Experience with reviewing manufacturing validation documentations and change management experience is crucial.

Position Summary

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. This position may execute tasks and play a consultative role by partnering across business functions, contract manufacturers, and suppliers.

This individual may assist in identifying and obtaining data needed, and ensuring that its effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

This individual will be the key Regulatory Affairs contact for the manufacturing facility in Buffalo Grove, IL.

This is a broad scoped position with strong opportunity for growth and career development.

Main Responsibilities
  • May prepare or oversee such preparation documentation needed for product registration worldwide.
  • Assist in SOP development and review
  • Provide regulatory input to product lifecycle planning
  • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
  • Assist in the development of regional regulatory strategy
  • 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

Required -
  • At least three (3) years of regulatory affairs experience
  • FDA/EU or international regulatory experience is required.
  • Bachelors degree (or equivalent combination of Education and Work Experience) is required.


Preferred -
  • Experienced in medical devices with class II or III PMA products preferred.
  • 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.)


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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