Global Regulatory & Product Compliance Leader

☞ Cytiva

View: 184

Update day: 25-04-2024

Location: Mellingen Aargau AG

Category: Legal / Contracts

Industry: Medical Equipment Manufacturing Biotechnology Research Pharmaceutical Manufacturing

Job type: Full-time

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Job content

Be part of something altogether life-changing!Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term. Your health and wellbeing are important to us and together we will not compromise on safety in the workplace or the environment.Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.What You’ll DoThe Regulatory and Product Compliance Leader will partner internally and globally with external stakeholders to manage all Regulatory activities that guarantee our regulatory compliance supporting the business growth.
  • Manage the global Regulatory team that will include:
    • Regulatory Affairs
    • Product Compliance
    • Customer Regulatory support
    • Regulatory intelligence
  • Manage global Regulatory activities providing guidance proactively & driving regulatory/compliance end-end activities from NPI to post market surveillance responsibilities.
  • Contribute and support International Trade Compliance from the regulatory perspective to guarantee smooth business activities & Compliance globally, for all product areas
  • Conduct & support audits across all sites and product lines, ensuring that staff members are prepared for participating & leading regulatory inspections and audits.
  • Assist in facilitating client audits and regulatory inspections.
  • Maintain a healthy customer focus and provide guidelines and support, amongst others include, not exclusively: timely CCN, updated technical documentation, responsive response to customer queries.
  • Build, develop & maintain the Regulatory expertise to adequately:
    • Drive awareness of regulation changes impacting our customers, such as cGMP
    • Proactively participate in Industry forums to develop industry guidelines and standards impacting our business areas/products
    • Train and develop associates on new regulations and Guidelines
  • Accountable for setting & monitoring Regulatory KPI’s including, reporting on performance/ trend insights within business reviews.
Functional responsibility: Regulatory AffairsShared responsibility: QA, R&D, International trade, Customer services, Product management amongst othersWho You Are
  • Bachelor’s degree and minimum 12 years work experience in a Quality or Regulatory Assurance related field. In particular with Regulatory experience in the Life Sciences Industry.
  • Experience on Medical Device Regulations, filings, and renewal process globally.
  • Demonstrated knowledge of all regulations and product compliance standards that apply to the product commercialized across the Cytiva/Biotechnology business
  • Working knowledge of manufacturing processes, product assembly, materials, and properties.
  • Ability to adapt to new business areas and requirements.
  • Demonstrated knowledge of Quality Management System tools & Regulatory/Compliance requirements, with proven ability to effectively communicate within all levels of the organization.
  • Comprehensive knowledge of Quality Systems, which ensure that products, processes, and services consistently meet or exceed the desired quality & regulatory standards, including as a minimum compliance to ISO 9001, ISO 10993, FDA 21 CFR Part 820 and ISO 13485.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.
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Deadline: 09-06-2024

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