The Opportunity
This position works out of our Des Plaines, IL location in the Abott Molecular Division. Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.
What You’ll Work On
As a Senior Regulatory Affairs Specialist , you’ll support the regulatory department to ensure business processes are efficient and compliant.
You’ll work with different business functions; help gather and present data for product registration worldwide and prepare or oversee the preparation of necessary documentation.
This is an individual contributor role.
Areas you will work on if hired :
Regulatory Compliance : Understand and apply regulatory requirements, and prepare and submit regulatory documents.
Documentation : Compile, review, and submit necessary paperwork for product registration.
Knowledge : Stay informed about regulatory guidelines, policies, and standards.
Agency Interaction : Know the structure and processes of regulatory agencies.
Product Laws : Understand laws related to products, promotion, advertising, and labeling.
Guidelines : Follow domestic and international regulatory guidelines, including Quality System Regulation 21CFR 820 and IVDR (EU) 2017 / 746.
Skills Needed :
Project Management : Create project plans and timelines and manage complex information.
Analytical Thinking : Think critically and make informed decisions.
Technical Knowledge : Understand various technical options and their business impact.
Ethical Judgment : Make ethical decisions within policy and regulations.
Business Acumen : Understand business functions and relationships.
Regulatory Strategy : Help define regulatory strategies and solve issues.
Communication : Work with different management levels and coordinate activities.
Leadership : Train others, lead projects, and provide technical guidance.
Required Qualifications
Bachelor's degree (or equivalent) Science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
3+ years of experience in similar role in a regulated industry
Preferred Qualifications
PMA (Premarket Approval) experience for US
MDR / IVDR experience for EU
Health Canada and WHO experience is ideal
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