Medical Devices-assessor/ Auditor

Job Title Medical Devices-Assessor AuditorJob Location Ahmedabad Gujarat IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level About UsWe are the independent expert in assurance and risk management Driven by our purpose to safeguard life property and the environment we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence As a trusted voice for many of the worlds most successful organizations we use our knowledge to advance safety and performance set industry benchmarks and inspire and invent solutions to tackle global transformations About SCPAWe help our customers respond to the increased demand for trust and transparency around products assets supply chains and ecosystems driving the transformation of the assurance industry Whether certifying products sharing claims or optimizing and decarbonizing supply chains DNV helps companies manage risks and realize their long-term strategic goals improving ESG performance and generating lasting sustainable results Drawing on our wide technical and industry expertise we work with companies worldwide to bridge trust gaps among consumers producers and suppliers About The RoleWe have a opportunity for a Medical Device Assessor Auditor to join our India Team The successful candidate will be responsible for planning and conducting audits assessments in accordance with ISO 13485 EU MDR and MDSAP standards and related eg IMDR Key AccountabilitiesTechnical Compliances Accreditation Requirements and collaborating with a Team of Auditors Assessors Conduct audits either desk-based or on clients sites in accordance with established procedures maintaining a high standard of service delivery that ensures effective customer relationships Conduct Technical File reviews specific for products being authorized Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business Complete specific projects in relation to medical device procedures processes systems and documentation If required undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation approval requirements Project manage auditing teams as appropriate to maximize efficiencies enhance client satisfaction and ensure compliance with standards To be considered for this role youll require about 10 years of professional experience in relevant field of healthcare products or related activities e g work in medical devices industry such as research and development manufacturing quality management regulatory affairs work in health services universities foundations or other institutions carrying out inspections audits clinical evaluations experimental and or clinical research including notified bodies work in the application of device technology and its use in health care services and with patients testing devices for compliance with the relevant national or international standards conducting performance testing evaluation studies or clinical trials of devices 5 years relevant professional experience in quality management is essential In addition to the above youll also need to demonstrate the following An excellent working knowledge of medical device management systems standards and medical device compliance auditing techniques Good knowledge of ISO 13485 MDD 93 42 EEC Indian Medical Device Regulations and their application Knowledge of MDR 2017 745 MDSAP IMDR Work experience in positions with significant QA Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active non active devices Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The Following Attributes Are Essential Work actively with a Team of Assessors Auditors Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves Annual Sick Compassionate Local Public Marriage Maternity Paternity Medical leave Medical benefits Insurance and Annual Health Check-up Pension and Insurance Policies Group Term Life Insurance Group Personal Accident Insurance Travel Insurance Training and Development Assistance Training Sponsorship On-The-Job Training Training Programme Additional Benefits Long Service Awards Mobile Phone Reimbursement Company bonus Profit share Benefits may vary based on position tenure contract grade level DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender religion race national or ethnic origin cultural background social group disability sexual orientation gender identity marital status age or political opinion Diversity is fundamental to our culture and we invite you to be part of this diversity About You University or technical college degree or equivalent qualification in relevant sciences such as Medicine Pharmacy Chemistry Biochemistry Biology Microbiology Biotechnology Health Technology Toxicology Physics Biophysics Material Science Biomedical Engineering Computer Software Technology Engineering Nursing Quality Management Qualified MDR Assessor from a reputed EU Notified Body desirable Experience with scientific literature searches or peer review in the medical context Fluent in written and spoken English Experience working with Various Digital Tools Excellent organizational and professional communication skills Lifelancer is a talent-hiring platform in Life Sciences Pharma and IT The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains 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