Global Labeling Specialist - Devices

This role is open for candidates currently located in Poland / Hungary / Czech / Croatia / Romania only.About Freyr

Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.

Why Freyr?

At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint , we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.

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If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions.

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Please apply to this job post or you can visit our Careers page for more openings

Visit our Careers page at (https://www.freyrsolutions.com/careers/current-positions) to explore current job openings and submit your application.

Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!

Title : Senior RA Specialist - Labeling

Location : Poland / Hungary / Romania / Croatia / Czech

OBJECTIVES/PURPOSE:

• Support the Device Global Labeling Lead (Device GLL) in fulfilling labeling responsibilities.
• Provide task-based and coordination support to Device GLL for global responsibilities and milestones for both combination and standalone devices (including Software as a Medical Device [SaMD]).
• Provide operational and strategic support to Device GLL for global responsibilities towards local affiliates (LOC).
• Support the Device GLL in tactical labeling operations activities for US and EU device labeling.
• Manage successful implementation of labeling operations activities for device labeling, including artwork and electronic approval of IFUs, carton labeling, etc.

ACCOUNTABILITIES:

• Support evaluation and implementation of labeling changes (e.g., content deviation/deferral requests, SaMD localization, Core IFU creation, device labeling requirements checklist updates, and IFU content comparisons) in close collaboration with Device GLLs.
• Ensure accuracy, consistency, and compliance of device and combination product labeling by performing document reviews, label comparisons (e.g., IFUs across regions), and secondary checks of labeling tools and checklists, and compares final agency approved combination product labeling against the last submitted version and provides any additional differences, if any, to Device GLL
• Support GLL by conducting the operational labeling activities including but not limited to: Coordinating/scheduling LWG, Pre-GLOC, and GLOCs, prepare labeling documents for meetings, and update labeling documents as per meeting outcomes, update EDMS and submission tracking system, and perform documentation impact and gap assessments.
• Support LWGs, perform label review, develop pre-GLOC and GLOC slides for the GLL upon request.
• Manage LOC deferrals, local exceptions and maintain various labeling trackers
• Support Health Authority Inspections (US, EU, and Global) and associated labeling information requests.
• Manage Device Labeling Operations tasks including but not limited to: EDMS management of Device Labeling deliverables and approvals, Trackwise Change Control tasks, artwork system (FOCUS) activities, translations management (both IFU/label/packaging and software graphic user interface strings)- Be responsible for working with suppliers for translation services where required, partner with artwork and product design groups on device labeling artwork deliverables, and partner with the Product labeling ops lead for combination product deliverables.
• Performs quality system updates by creating and facilitating process maps and swim lanes, and editing and authoring SOPs, WIs, Job Aids, etc. for device labeling roles and responsibilities. Partners with Global Labeling Compliance and SMEs for updates to documentation.

CORE ELEMENTS RELATED TO THIS ROLE:

• Excellent communication, organizational, and team collaboration skills
• Must work effectively with global work associates, demonstrating strong interpersonal skills combined with cultural sensitivity
• Ability to interact effectively at high levels, between Global Labeling and stakeholders, manage and resolve issues and to provide effective feedback
• Must be able to handle multiple projects simultaneously while maintaining high quality results.
• Must provide and implement innovative solutions to unique situations.
• Must be able to recognize potential conflict and escalate when necessary
• Demonstrate leadership presence and confidence with the ability to collaborate with teams in an matrixial operating model

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BS Degree in a science discipline. Advanced degree preferred.
• 8+ years of medical device or combination product within a pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.
• Understanding of scientific principles and regulatory/quality systems relevant to device development.
• Experience managing documentation changes and approval in electronic documentation systems.
• Strong oral and written communications (English fluency, both written and verbal REQUIRED.)
• Focus on accuracy and strong attention to detail is a must
• Ability to prioritize while managing multiple projects of varied complexity and criticality and to adhere to timelines while demonstrating integrity and adaptability.
• Strong interpersonal skills combined with cultural sensitivity for successful global collaboration
• Willingness to provide and receive constructive feedback
• Self-motivated, self-starter with the ability to work with some direction and in a team with a flexible mindset