Regulatory Affairs Associate

Title:

Regulatory Affairs Associate Location:

Alameda, CA Duration:

12 Months 100% Onsite Summary 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. 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, Visio and SharePoint. Consultants Eligible Benefits Upon Waiting Period Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account (for High-Deductible Health Plans) Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit) Supplemental Life Insurance Short Term Disability (coverage varies by state) Long Term Disability Critical Illness, Hospital coverage, Accident Insurance MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance 401(k) 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.