Regulatory Device Labelling Specialist 1 year fix temp contract
Regulatory Device Labelling Specialist 1 year fix temp contract
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Job Description
Position Summary: The Device Labelling Specialist on behalf of the SGL Europe labeling group is responsible for developing and maintaining endtoend product labelling support of aesthetics labelling in accordance with European Union regulatory requirements (MDR 2017/745. This role entails collaboration with crossfunctional 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.
- Crossfunctional 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 :
Qualifications:
- Bachelors 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
Additional Information :
Company Values: At AbbVie we foster a culture of innovation and collaboration. We are committed to developing graduates providing them with the opportunity to make meaningful contributions to healthcare.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
