Regulatory Affairs Specialist

hace 4 semanas

Caimito Barrio, Puerto Rico Abbott A tiempo completo
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. Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.
  • An excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor's degree.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity

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.

As an individual contributor in the function of 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.

The individual will be reviewing Labeling, Advertising and Promotional materials, determining risk, identifying data needed, obtaining data and ensuring that the information is reliable and effectively presented to substantiate claims. You'll also have opportunities to participate in worldwide regulatory submissions. This is a broad-scoped position with strong opportunity for growth and career development based on performance.

This role is located onsite position at our Alameda, CA office.

What You'll Work On
  • 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.
Required Qualifications
  • 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.

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