Title: Regulatory Affairs Associate
Location: Alameda, CA
Duration: 12 Month Assignment
100% Onsite
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, nutritional’s, 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.
- Internal negotiation skills
- Pays strong attention to detail.
- Manage projects. Create project plans and timelines.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Applies business and regulatory ethical standards.
- Excel exp is a Must and should be at Intermediate or Expert level as will be doing formulas, V-lookups and pivot tables.
- PowerPoint is also a must because will need to do PowerPoint presentations.
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.
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, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
