Regulatory Device Labelling Specialist (1 year fixed temporary contract), Madrid
Client: AbbVie
Location: Madrid, Spain
Job Category: Other
EU work permit required: Yes
Job Views: 1
Posted: 30.04.2025
Expiry Date: 14.06.2025
Job Description
Position Summary: The Device Labelling Specialist, on behalf of the SGL Europe labeling group, is responsible for developing and maintaining end-to-end product labelling support for aesthetics labelling, in accordance with European Union regulatory requirements (MDR 2017/745). This role entails collaboration with cross-functional teams to manage translations, ensure compliance, and enhance the product labelling strategy for aesthetics in the market and those under development.
Key Responsibilities:
* Labelling Strategy Development and Regulatory Compliance:
o Ensure consistency of aesthetics labelling globally across assigned products and in compliance with AbbVie policies and procedures.
o Stay informed on relevant legislation to assess potential impacts on aesthetics labelling.
* Cross-functional Collaboration: Collaborate with international teams for translations globally.
* Documentation Management:
o Review labelling documents, ensuring accuracy and consistency across products, and meet submission and artwork timelines.
o Manage the product information within the RIM system.
o Ensure packaging and labelling meet all legal specifications, including updates to SSCP, Patient Implant card, Patient insert, and labelling.
* Artwork and Packaging:
o Collaborate with Operations and Regulatory colleagues to coordinate packaging artwork and implementation.
o Implement changes to labelling content and artwork based on regulatory updates and market needs.
* Project Management:
o Lead product updates according to project timelines.
o Present updates and forecasts to stakeholders and affiliates regularly.
Qualifications:
* Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, or a related field.
* Experience or internship in regulatory affairs within the pharmaceutical or medical device industry is advantageous.
* Strong project management and communication skills (written and oral).
* Ability to work independently and across time zones.
* Proficient in English; additional European languages are a plus.
* Proactive, flexible, with a strong team ethic.
* Ability to multitask and adapt to changing deadlines.
* Proficiency in tools such as Microsoft Word, Excel, Teams, Adobe, and document management systems.
Additional Information:
Company Values: At AbbVie, we foster a culture of innovation and collaboration. We are committed to developing graduates, providing opportunities to contribute meaningfully to healthcare.
AbbVie is an equal opportunity employer committed to integrity, innovation, transforming lives, and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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