Labeling and Compliance Specialist

Vor 5 Tagen

Zug, Zug, Schweiz Randstad Switzerland Vollzeit

Are you a compliance expert with a knack for precise labeling and a passion for ensuring product integrity?

For one of our Clients, a medical diagnostics company, we are looking for a dedicated and proactive
Labeling and Compliance Specialist
to join a Subchapter of Compliance Support team in Rotkreuz.

In this pivotal role, you will be working with other members in our sub-chapter in ensuring seamless product labeling and process integration during the transfer of a key In-Vitro Diagnostic (IVD) instrument from one manufacturing site to another.

This is an exciting opportunity to lead critical compliance activities, impact patient safety, and contribute directly to our mission of advancing healthcare.

General Information:

  • Start date: January 2026
  • Latest start date: February 2026
  • End date: 1 year
  • Contract: temporary contract via Randstad
  • Extension: likely
  • Workplace: Rotkreuz
  • Workload: 80-100%
  • Home Office: up to 3 days / week
  • Travel: up to 2x / year
  • Working hours: standard

Tasks & Responsibilities:

  • Labeling Strategy & Execution:
    Spearheading the development and implementation of comprehensive labeling strategies for the IVD instrument transfer, ensuring full compliance with global regulatory requirements (e.g., EU IVDR, FDA, NMPA etc.) and internal standards.
  • Driving QMS-Related Changes:
    Managing and overseeing all QMS-related documentation and process updates necessitated by the manufacturing site transfer, including procedures, work instructions, and records, to maintain a robust and compliant quality system.
  • Cross-Functional Collaboration:
    Acting as the primary liaison between various stakeholders, including Regulatory Affairs, Quality Assurance, R&D, Supply Chain, and the transferring/receiving manufacturing sites, to ensure alignment and effective execution of labeling and compliance activities.
  • Risk Assessment & Mitigation:
    Identifying potential compliance risks associated with the transfer, developing mitigation strategies, and actively resolving any issues related to labeling and QMS changes.
  • Documentation:
    Ensuring all labeling artwork, technical documentation, and QMS records are accurately developed, reviewed, approved, and maintained.
  • Project Management Support:
    Contributing actively to project timelines, milestones, and deliverables for the instrument transfer, specifically focusing on the compliance and labeling work packages.
  • Continuous Improvement:
    Proactively identifying opportunities to enhance existing labeling processes and QMS elements, fostering a culture of continuous improvement within the Subchapter Compliance Support.

Must Haves:

  • Academic degree in a scientific, engineering, or regulatory discipline.
  • Min. 1 year proven experience in
    medical device/IVD product labeling and/or Quality Management Systems
    within the healthcare or life science industry.
  • Demonstrated experience in managing and overseeing QMS-related documentation (e.g., procedures, work instructions, records) required to maintain a compliant quality system.
  • Solid understanding of
    core global IVD/Medical Device regulations and standards
    (EU IVDR, FDA 21 CFR Part 820, ISO 13485)
  • Experience with product transfers or significant change management is highly advantageous.
  • Practical experience and understanding of Good Manufacturing Practice (GMP) principles and their application within a regulated environment.
  • Language Skills: Fluency in English and German B2 (written and spoken).

  • Labeling and Compliance Specialist

    Vor 3 Tagen

    Zug, Zug, Schweiz Coopers Group AG Vollzeit CHF 60'000 - CHF 120'000 pro Jahr

    Labeling and Compliance Specialist (m/w/d) Banking / Finance / Insurance Your responsibilities: Labeling Strategy & Execution: Spearheading the development and implementation of comprehensive labeling strategies for the IVD instrument transfer, ensuring full compliance with global regulatory requirements (e.g., EU IVDR, FDA, NMPA etc.) and Roche internal...

  • Compliance Officer

    vor 21 Stunden

    Zug, Zug, Schweiz Bitcoin Suisse AG Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    Bitcoin Suisse is the Swiss crypto-native pioneer and trusted gateway to crypto asset investing. As the leading crypto financial service provider in Switzerland, we operate across the most relevant crypto exchanges and provide brokerage, custody, staking and other crypto-related services at the forefront of technical innovation. We are as dedicated to our...

  • Site and Internal Communications Specialist

    Vor 5 Tagen

    Zug, Zug, Schweiz Real Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    Site and Internal Communications SpecialistDuration:01/12/2025 to 31/12/2026Location:Zug, CHSite and Internal Communications Specialist:Responsible for delivering multichannel communications and supporting internal engagement across international regions. Works with the Corporate Communications Lead to implement plans that connect employees and drive...

  • Compliance Specialist Crypto, 80-100

    vor 2 Wochen

    Zug, Zug, Schweiz JayBee AG Vollzeit CHF 80'000 - CHF 100'000 pro Jahr

    Looking for a forward-thinking challenge with strong development potential?Here's your chance to be part of the FinTech, DLT & crypto evolution. JayBee, a leading company in this field specializing in Regulatory, Risk & Compliance, is strengthening its team.Join us and make an impactAufgabenAdvising financial intermediaries on regulatory, legal and...

  • Sourcing Specialist

    Vor 7 Tagen

    Zug, Zug, Schweiz Planet Pharma Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    ***Specialist, Global Direct Sourcing - Contract (Possibility to be Permanent) - Hybrid in Zug***About the RoleWe're looking for aSpecialist, Global Direct Sourcingto join our clients Global Sourcing organization. This role supports the development and implementation of sourcing strategies, category management, and contract lifecycle management across global...

  • Finance Compliance Transformation Manager

    vor 2 Wochen

    Zug, Zug, Schweiz Johnson & Johnson Innovative Medicine Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Senior Payments Specialist

    Vor 5 Tagen

    Zug, Zug, Schweiz AMINA Bank Vollzeit CHF 100'000 - CHF 120'000 pro Jahr

    At a Glance: The Story Behind AMINAFounded in April 2018 and headquartered in Zug, AMINA Bank is a pioneer in the financial industry. In August 2019, AMINA received a Swiss banking and securities dealer license from FINMA. The broad, vertically integrated spectrum of services, combined with the highest security standards, make AMINA's value proposition...

  • Senior Payments Specialist

    Vor 5 Tagen

    Zug, Zug, Schweiz AMINA GROUP Vollzeit CHF 90'000 - CHF 120'000 pro Jahr

    At a Glance: The Story Behind AMINAFounded in April 2018 and headquartered in Zug, AMINA Bank is a pioneer in the financial industry. In August 2019, AMINA received a Swiss banking and securities dealer license from FINMA. The broad, vertically integrated spectrum of services, combined with the highest security standards, make AMINA's value proposition...

  • Quality System Specialist

    Vor 5 Tagen

    Zug, Zug, Schweiz SHL Medical Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients....

  • Quality System Specialist

    Vor 5 Tagen

    Zug, Zug, Schweiz SHL Medical Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients....