Trwa ładowanie. Prosimy o chwilę cierpliwości.
Michael Page
Data aktualizacji: 2019-08-12
Data aktualizacji: 2019-08-12 Aplikuj

Senior Director Quality Assurance and Regulatory Affairs


Our client is a global Medical Devices player dedicated to the diabetes management and self-care.
What's on Offer
Help people around the globe leading a healthier life Join a global player in the Medical Devices arena Competitive Salary Package
Job Description
Key responsibilities (Quality Assurance & Compliance)
  • Lead the company's product quality and reliability process, systems.
  • Ensure that processes necessary for the quality management system are established, implemented and maintained.
  • Responsible for the company's Quality Compliance / Quality Assurance ensuring product quality and reliability meeting and exceeding customer expectations.
  • Develop and execute design assurance strategy in support of new product development and sustaining business activities while ensuring compliance to regulatory compliance.
  • Effectively create and support process improvement, harmonisation, and simplification efforts.
  • Build integrated quality system and culture in all plants.
  • Provide effective leadership support, training, and mentor-ship to the Regulatory and Quality organisation (and other functional teams e.g. R&D, Manufacturing, Commercial, etc.).
  • Ensures the proper interface of the quality function to product development, manufacturing, engineering/maintenance, and other areas as required.
Key Responsibilities (Regulatory Affairs):
  • Provide management and leadership to the Regulatory Affairs organisation in the development and implementation of regulatory strategies and processes to gain product approvals.
  • Responsible for keeping management team informed about regulatory status of products and significant regulatory issues.
  • Act as Company Management Representative for regulatory authorities providing counsel, training, and interpretation of FDA and other regulatory issues to company personnel.
  • Responsible for the preparation and conduct of all inspections/audits by any regulatory authority and customers.
  • Provide leadership, training and interpretation of MDR, MDSAP and FDA and other regulatory requirements to all company associates within the Regulatory and Quality organisations and other functional teams.
  • Oversee preparation and filing of all regulatory documents with FDA, EPA, Health Canada, ISO and other relevant regulatory agencies.
  • Develop and maintain external relationships with key opinion leaders and regulatory officials.
  • Direct the development of systems, practices and processes to ensure effective ongoing review of product design and/or manufacturing changes and post-market surveillance.
  • Provide leadership and direction for significant regulatory changes that may impact compliance status or represent significant business risk.
The Successful Applicant
Qualifications and Key Abilities:
  • Bachelor's degree, preferably in life sciences, engineering, or business.
  • Minimum of 15 years progressive experience in Regulatory Affairs, Clinical Affairs and Quality Assurance.
  • Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development/clinical manufacturing and commercial operations.
  • Has an excellent understanding of Quality requirements globally and specifically for EU and the US.
  • Proven expertise in the design and implementation of quality processes in a world-class medical device manufacturing organisation.
  • Must have technical competences and knowledge of device product design, manufacturing, process design and improvement and act as an open and accessible resource to peers.
  • Must have a track record of success and a broad understanding of contemporary quality practices for medical device and combination product platforms.
  • Extensive relevant experience applying Quality risk management for device product development and manufacturing.
  • Experience with all phases of the product development life cycle, including concept, design, implementation, verification and validation activities necessary for product commercialisation.
  • Extensive experience in GMP and other Regulatory compliance requirements.
  • Experienced in regulatory filings for US (510(k), EU and other key countries/regions.
Key Personal Skills:
  • Self-confidence and the ability to work with all levels of organisation.
  • Calm presence in tense situations and an ability to address competing priorities.
  • Able to influence direct reports, leadership staff, internal and external stakeholders.
  • Able to make decisions quickly that drive Company goals and objectives.
  • Able to effectively communicate in both written and verbal forms.
  • Ability of asking the right questions and making the tough decisions.
  • Operates in a way that never compromises ethics and integrity.
  • Ability to selecting and developing talent.
  • Ability to understand and adapt to different cultures and market needs.
Travel Requirements:
  • International travel is required for this role = 30%-40%

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