IVDR Experienced Assessor

Description

• Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business.
• Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
• Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager.
• Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.
• If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements.
• Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate and to draw up records and reports on the corresponding audits.

Requirements

• Pharmacy, Pharmacology, Toxicology
• Work experience in positions with significant QA Regulatory or management systems responsibility.
• Experience with Risk Management EN ISO 14971.
• Biomedical science - e.g. hematology, virology, molecular diagnostics
• Medical device experience from auditing/work.
• We conduct a pre-employment background check and drug screen.
• Medicine, Veterinary Medicine
• Experience with Harmonized medical device standards for In-Vitro diagnostic medical devices.
• Should have a flair for technical writing, essential for exhaustive report writing.
• Medical Technology or Biotechnology
• Chemistry or Biochemistry
• Experience of working under own initiative and in planning and prioritizing workloads.
• An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques.
• Experience auditing against recognized standards.

Benefits

• Company provided life insurance, short-term, and long-term disability benefits
• Generous paid time off (vacation, sick days, company holidays, personal days)
• Charitable Matched Giving and Volunteer Rewards through our Impact Program
• Flexible work schedule with hybrid/remote opportunities
• Career advancement opportunities
• Employer-paid, therapist-led, virtual care services through Talkspace
• 401(k) with company match
• Multiple Medical and Dental benefit plans to choose from, Vision benefits
• Volunteer time off (VTO) paid by the company
• Spending accounts – FSA, Dependent Care, Commuter Benefits, company-seeded HSA
• Education reimbursement program

Training + Development

Interview process

Visa Sponsorship

Security clearance