Senior Regulatory Affairs Specialist (New Product Development)

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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.

ABOUT ABBOTT DIAGNOSTICS:

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott's life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations - with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Our location in Lake Forest, Illinois currently has an opportunity for a Senior Regulatory Affairs Specialist.

WHAT YOU'LL DO - Please Modify

• Participate as the regulatory core functional product team member for the organization's Core Diagnostics regulatory team

• Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to determine regulatory strategies for approval/clearance/registration for International and US markets for new products in development

• Survey the organization's country specific regulatory experts to obtain country-specific regulatory feedback during product development and at the request of the core functional product team. Compile information to provide to core functional product teams.

• May prepare documentation needed for registration worldwide or may oversee such preparation

• Assist in SOP development and review. Provide regulatory input to product lifecycle planning.

• Determine and communicate submission and approval requirements to the core functional product team.

• Participate in risk benefit analysis for regulatory compliance.

• Assess the acceptability of quality, preclinical and clinical documentation for submission filing.

• Compile and help prepare regulatory submission to authorities (US and International)

• Monitor impact of changing regulations on submission strategies.

• Monitor applications under regulatory review. Communicate timelines and review status to the core functional product team.

• Assess external communications relative to applicable regulations.

• Assist with label development and review for regulatory compliance before release.

• Analyze the input of cumulative product changes to current product submissions.

• Assess export requirements for products labeled for research or investigational use.

• Participates as a Team Member: Actively contributes to the team process, commits to team goals, expresses opinions and shares ideas freely.

• Contributes to the creation of the team's mission objectives and strategies, accepts team decisions and works toward their implementation.

EDUCATION AND EXPERIENCE YOU'LL BRING

Required - Do Not Modify
  • Bachelor's degree in related field, or equivalent combination of education and work experience
  • Master's degree in regulatory affairs preferred and may be used in lieu of direct regulatory experience.
  • Minimum 3-4 years experience in a regulated industry (e.g., medical products, nutritionals).
  • 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)


Preferred - Please Modify
  • Bachelor's degree in science (biology, chemistry, biochemistry, microbiology, immunology, medical technology, pharmacy/pharmacology), engineering, or another medically related field.
  • Advanced degree in a technical area is helpful. Certification (such as RAC from the Regulatory Affairs Professionals Society) is a plus
  • Experience writing, packaging, and submitting product submissions


WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:
  • 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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