About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow and learn, care for yourself and your family, be your true self and live a full life. You will have access to:
* Career development with an international company where you can grow the career you dream of.
* A company 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.
Position: Specialist Regulatory Affairs (Temporary) - Madrid
Primary Function / Primary Goals / Objectives
Provide support for the regulatory department to ensure efficient and compliant business processes. Prepare and submit documentation for registration/notification for medical nutrition, direct-to-consumer products and medical devices, and reimbursement for medical nutrition.
Major Responsibilities
* Responsible for compliance with applicable local and divisional policies and procedures.
* Provide regulatory input to product lifecycle planning.
* Implementation of regulatory requirements on product registration, reimbursement, and promotional materials.
* Ensure regulatory approval for placing clinical nutrition products in the market, infant and adult FSMP.
* Ensure reimbursement approval for placing clinical nutrition products in the market, infant and adult FSMP.
* Ensure compliance with all relevant statutory requirements and all relevant internal procedures.
* Provide regulatory assessment for new and existing products.
* Nutritional products label review.
* Ensure registration approval for new medical devices and also for modifications.
* Revision and approval for all promotional materials (medical nutrition, food supplements, and medical devices).
* Liaison with Division Regulatory Affairs groups.
Education
* Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
* English Level C1.
Background / Skills / Knowledge
Does not specifically require regulatory 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.
Accountability / Scope
Individuals execute and manage technical and scientific regulatory activities, understand regulations and guidance. Individual works under minimal supervision and may independently determine and develop approaches to solutions. Work is reviewed upon completion for adequacy in meeting objectives. Communicate effectively verbally and in writing with diverse audiences/personnel. Write and edit technical documents. Work with cross‑functional teams.
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