Regulatory Affairs Specialist II

Opportunity As part of product development teams, the Regulatory Affairs Specialist executes product registration submissions, progress reports, supplements, and amendments. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liaison throughout product lifecycle. Participates in product plan development and implementation, regulatory strategy, risk management. Ensures timely approval of new medical devices and continued approval of on-market products and product changes. Serves as regulatory representative to marketing, research teams and regulatory agencies. Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Core Responsibilities Prepares robust regulatory applications for FDA or other international regulatory agencies. Creates, reviews and approves engineering changes. Reviews and provides input on device labeling. Provides review and analysis of applicable regulatory guidelines and project regulatory assessments. Reviews and evaluates communications to ensure they comply with regulatory standards. Maintains domestic and international medical device regulations and updates. May interface directly with FDA and other regulatory agencies. Supports product release process by creating GTS licenses or reviewing and approving requests for product release. Reviews protocols and reports to support regulatory submissions. Supports all business segment initiatives per divisional management. Complies with FDA and international regulations, policies, procedures, and task assignments. Maintains positive and cooperative communications with all levels of employees, customers, contractors, and vendors. Required Qualifications Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical field, or equivalent education and work experience. Master’s degree preferred. 2–3 years experience in a regulated industry (medical products, nutritionals). Regulatory area preferred, but experience in quality assurance, R&D/support, scientific affairs, operations, or related area acceptable. Demonstrated knowledge of regulatory history, guidelines, policies, standards, practices, and precedents. Knowledge of FDA and international regulatory guidelines, policies, regulations and ethical guidelines. Strong communication skills (verbal and written), ability to work with cross‑functional teams, negotiate, manage projects. Attention to detail, analytical thinking, organization, and ability to exercise judgment within defined practices. Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio, SharePoint). Preferred Qualifications 1+ year of Regulatory Affairs or Quality experience within Medical Devices. Experience reviewing labeling, promotional and advertising materials. Knowledge of Regulatory and/or Quality Systems history and guidelines. Certification such as RAC from the Regulatory Affairs Professionals Society. Experience with Class II or Class III medical devices. Other Information Base pay range: $81,500.00 – $141,300.00. Location: United States (Sylmar, CA; Scottsdale, AZ). Travel: None. Work shift: Standard. Required conditions: Continuous sitting for prolonged periods, keyboard use ≥ 50% of workday. Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law. English: Espanol: #J-18808-Ljbffr Abbott Laboratories