Valeant Pharmaceuticals

Manager EU MDR, Global Device Complaints Management

Job Location US-NJ-Bridgewater
Job ID
Pos. Category
Pos. Type
Full Time


Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.


The incumbent will be responsible for the leadership and management of the implementation of Materiovigilance activities associated with EU- Medical Device Regulations (EU-MDR) across the Valeant company. As such, the incumbent will be a key contributor the EU-MDR project management team. The incumbent will lead the implementation of process improvements regarding complaint handling, medical device reporting and global complaint handling strategies.


This position will supervise direct reports. 



  • Provides daily leadership to teams concerning EU-MDR implementation activities for global Materiovigilance.
  • Manage, train and motivate team leaders and/or members.
  • Generates, revises and implements robust and compliant complaint handling and medical device event reporting and other required standard operating procedures for Materiovigilance.
  • Develops training materials as required and ensures all team complete trainings on assigned procedures, policies, work instructions and guidelines.
  • Reviews adverse event reporting determinations to ensure they meet applicable regulatory reporting requirements prior to submission, when required.
  • Develops and implements project tracking and trending data collection tools.
  • Identifies and implements business process efficiencies to ensure timeliness
  • metrics are consistently met.
  • Strong skills in working and leading change within a global team.
  • Acts as Subject Matter Expert for all EU-MDR materiovigilance activities.
  • May be required to support  regional Compliance audits, domestic and international regulatory agency inspections and Notified Body audits
  • Completes documentation associated with personal performance reviews and communicates personnel reviews to team members.
  • Develops personnel goals and objectives.
  • Routinely interacts and contributes to the EU-MDR, Quality Assurance, External Manufacturing Quality Assurance, R&D, Customer Service and Medical Affairs in order to ensure robust process and procedures are developed and implemented.
  • Assesses critical complaint events and engages appropriate management, when required.
  • Acts as designee for Director, Materiovigilance Operations when required.
  • Contributes to preparation of quality agreements, safety data exchange agreements and other inter-company service agreements and provides feedback in a timely manner as.
  • May require up to 15% travel (domestic and international).
  • Position will be responsible for up to five (5) direct reports.
  • Contributes to Materiovigilance intelligence activities.
  • Participation in activities related to safety issues: Corrective and Preventative Action (CAPA), Field Safety Correction Action (FSCA), cooperation with other company departments on Field Safety Notices.



Key Relationships 


Internal customers/business partners:

  • EU-MDR Project team
  • Medical Affairs
  • Customer Service
  • Regulatory Affairs
  • Research and Development
  • Design Quality Assurance
  • External Manufacturing Quality Assurance.
  • Manufacturing Site Quality Assurance
  • Legal
  • Sales and Marketing
  • Quality Systems/Compliance

 External customers/business partners:

  • Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)


  • Bachelor of Science degree in a technical discipline (Engineering, Biomedical, Life Science, etc.) is required.
  • Minimum 5 - 7 years related work experience within a medical device or
  • pharmaceutical company required.
  • Minimum of 2 years experience in a senior lead or Supervisory role with direct oversight of personnel required.
  • Extensive/expert knowledge of reportability and vigilance regulations required.
  • Must have been directly involved in making reportability decisions and submitting medical device event reports.

Be Aware of Recruiting Fraud

Valeant is an EEO/AA employer M/F/D/V.


Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.


To learn more please read Valeant’s Job Offer Fraud Statement.



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