Medical Device Compliance Specialist

hace 3 semanas


Valencia, Valencia, España Edwards Lifesciences A tiempo completo
Job Title: Medical Device Compliance Specialist

Fulfill medical device regulations in the region, ensuring compliance with ISO13485 and other relevant requirements for designated complaint handling units. Investigate complaints, manage customer relationships, and prepare reports for regulatory bodies.

Key Responsibilities:
  • Investigate complaints, including moderately complex scenarios, to determine reportability to regulatory bodies.
  • Manage customer relationships and expectations during the complaint investigation and resolution process.
  • Prepare and submit reports to Competent Authorities, after review by a senior team member.
  • Identify problems and lead projects to improve processes, procedures, and practices.
Requirements:
  • Bachelor's Degree in a related field.
  • 3 years of experience in complaint handling or a related field.
  • Experience working in a medical device or healthcare environment.
  • Excellent written and verbal communication skills.
  • Proven expertise in MS Office Suite and ability to operate general office machinery.
What We Offer:
  • Competitive Compensation and Benefits package.
  • Flexible working hours and remote working options.
  • Pension plan and life insurance.
  • Medical plan and meal vouchers.
  • Service Awards and Enhanced Leave benefits.
  • Employee Stock Purchase Programme and Employee Assistance Programme.
  • Comprehensive Wellness programme, including gym membership reimbursement and fresh fruit in the office.

Benefits are regulated by an internal policy, which contains the full details regarding entitlement and conditions for the benefits. Benefits policy and components may vary by location.



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