Regulatory Affairs Specialist

2 weeks ago

Alameda, California, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott Laboratories 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.

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment. The individual may execute tasks and partner across business functions.

Key Responsibilities
  • Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input.
  • Assist with promotional content development and review for compliance before distribution.
  • Assist in Regulatory Affairs Ad & Promo SOP development and review.
  • Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed.
  • Determine and communicate promotional content and approval requirements to cross functional teams.
  • Assist compliance with product post-marketing approval requirements as needed.
Requirements
  • Bachelor's degree or an equivalent combination of education and work experience.
  • Minimum of 2 years' experience in a regulated industry (e.g., medical products, nutritionals, pharma, food). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents.
  • Work with cross-functional teams. Work with people from various disciplines and cultures.
  • Write and edit technical documents.
  • Negotiate internally.
  • Pay strong attention to detail.
  • Manage projects. Create project plans and timelines.
  • Think analytically and critically.
  • Organize and track complex information.
  • Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Apply business and regulatory ethical standards.
Preferred Qualifications
  • Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields.
  • 1+ year of Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of labeling, promotional, and or advertising materials is highly desired.
  • Prefer some knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; 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.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
  • Office programs skills to include Word, Excel, PowerPoint and SharePoint.
About Abbott

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.

We are committed to employee diversity and offer a range of benefits, including career development opportunities, free medical coverage, and a retirement savings plan.

Join us at Abbott Laboratories and be part of a team that is shaping the future of healthcare.

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