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Regulatory Compliance Manager EMEA – Diagnostics

Ensure compliance with regulations and company procedures in all countries in EMEA and Canada. Perform periodic audits of internal sites, service centers, third party distribution centers and dealers/distributors to identify potential regulatory compliance risks and implement corrective actions. Manage external and internal audits of the QMS in international locations including interfacing with sites and regional competent authorities during all the steps of identifying, reporting and finalizing any audit non-conformance.

ROLE ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Interpret and apply regulations to existing products to ensure compliance with these regulations in all EMEA and Canada sites, dealers and distributors.
  • Define, execute, monitor, collate, and publish audit schedules in coordination with divisional and corporate quality compliance teams.
  • Participate in global quality compliance teams and support implementation of harmonized procedures.
  • Ensure adherence to the company quality audit schedule in international sites.
  • Provide monthly reporting to regional and international management on the status of internal and external audits, open actions, overdue activities and future audits.
  • Interface with employees, dealers and distributors regarding quality compliance activities.
  • Interact with regulatory agencies in regards to audits and responses until closure.
  • Provide training to international employees on audit management.
  • Advise and guide management and other personnel in other departments on the interpretation and application of regulations impacting compliance activities.
  • Maintain current knowledge of current and proposed regulations, laws, guidelines standards, and initiatives. Assess impact and disseminate throughout the organization for continued regulatory and quality compliance.
  • Develop staff skills, abilities, and experiences for succession.
  • Perform other related duties as assigned.

EDUCATION AND EXPERIENCE

  • Bachelor or equivalent in biological sciences, life sciences, engineering or related discipline with the required skills, knowledge and abilities that are typically acquired through a minimum of 7 years’ experience in the in vitro diagnostics, medical device or pharmaceutical industries; with at least 4 of those years in a wide breath of compliance roles.
  • Must have certification as an ISO Lead Auditor
  • Must have experience interfacing with competent authorities regarding audit activities and resolution of observations.
  • Must have advanced knowledge of applicable regulations and standards related to medical devices in EMEA and Canada (ISO 13485, Medical Device Regulation, MDSAP, etc.)
  • Comfortable leading in a high pressure environment typical of regulatory audits.
  • Ability to independently plan, execute, and/or problem solve moderate to complex situations.
  • Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Must demonstrate initiative, balanced assertiveness working as a team player.
  • Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel
  • Ability to manage multiple projects.
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