Regulatory Device Labelling Specialist

Regulatory Device Labelling Specialist

AbbVie

Madrid, Spain

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 of aesthetics labelling, in accordance with European Union regulatory requirements (MDR 2017/745). This role entails collaboration with cross-functional teams to manage translations, to ensure compliance and to enhance the product labelling strategy for aesthetics in the market and those under development.

Key Responsibilities

• Labelling Strategy Development and Regulatory Compliance:
  • Ensure consistency of aesthetics labelling globally across assigned products and in compliance with AbbVie policies and procedures.
  • Stay informed on relevant legislation to assess potential impacts on aesthetics labelling.
• Cross-functional Collaboration: Collaborate with international teams for translations globally.
• Documentation Management: Review labelling documents, ensuring accuracy and consistency across products, and meet submission and artwork timelines.
  • Manage the product information within the RIM system.
  • Ensure packaging and labelling meet all legal specifications, including updates to Summary of Safety and Clinical Performance (SSCP), Patient Implant card, Patient insert and labelling.
• Artwork and Packaging: Collaborate with Operations and Regulatory colleagues to coordinate packaging artwork and implementation.
  • Collaborate with relevant teams to implement changes to labelling content and artwork, based on regulatory updates and market needs.
• Project Management: Lead product updates according to agreed project timelines.
  • Present updates and forecasts to internal and external stakeholders (vendors) and affiliates regularly.

Qualifications

• Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, or a related field.
• Previous experience or an internship in regulatory affairs or a related area within the pharmaceutical or medical device industry is an advantage.
• Strong project management and communication skills (written and oral).
• Ability to work independently and across different time zones.
• Proficient in English; additional European languages are a plus.
• A proactive and flexible approach, with a strong team mindset.
• Ability to multitask and adjust to changing deadlines.
• Proficiency in key tools such as Microsoft Word, Excel, Teams, Adobe, document management systems.

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