Regulatory Affairs Operations Specialist II (on-site)

Regulatory Affairs Operations Specialist II (on-site)

Apply locations United States - California - Sylmar

Time type Full time

Posted on Posted 26 Days Ago

Job requisition id 31093469

JOB DESCRIPTION:

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 student debt program and FreeU 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

We are currently hiring a Regulatory Affairs Operations Specialist II to work on-site at our Sylmar, CA location. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Additionally, will support necessary regulatory activities required for product market entry.

What You’ll Work On

• Daily support of product releases by preparing Global Trade Services (GTS) licenses for products, countries and business partners allowing shipment of product to achieve departmental and organizational objectives.
• Responsible for following SOPs for managing GTS licenses, additional release authorizations (ARAs) and tender support and overall regulatory operations activities.
• Have a full working knowledge of GTS license types, country regulatory and language requirements.
• Provide support for Product and Country Experts in the set-up for release of new and modified products globally.
• Acts as a regulatory representative responsible for review and analysis of GTS blocked orders, providing guidance and direction on regulatory compliance.
• Reviews and evaluates customer service requests and monitoring of email box for such requests, maintaining a high level of service and follow through on all communications.
• Ensure communications convey all necessary detail and adhere to applicable regulatory standards.
• Maintains positive and cooperative communications and collaboration with all levels of employees worldwide; customers, contractors, and vendors.
• Have a basic understanding of product lines being supported.
• Have full understanding of Windchill and SAP applications for research, problem solving and analysis of blocked orders and creation of GTS licenses.
• Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates and IT.
• Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Participates in projects affecting GTS licenses and performs other related duties and responsibilities, as assigned.

Required Qualifications

• Bachelor’s Degree OR an equivalent combination of education or work experience.
• 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Domestic and international regulatory guidelines, policies and regulations;
• Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization and diverse audiences.
• Strong analytical, organizational and follow-up skills, as well as attention to detail.
• Ability to manage projects, create timelines and plans.

Preferred Qualifications

• Bachelor’s Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
• Experience with medical device industry.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.