Medical Device Assessor

We have a new opportunity for a Medical Device Assessor to join our India Team. The successful candidate will be responsible for planning and conducting audits against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, MDR 745/2017 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

Job Responsibilities:

• Conduct assessments (either desk-based or on client’s 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 as requested by the Medical Devices Operations Manager.
• If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV GL policies and accreditation/approval requirements.
• Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.

Qualifications And Experience:

• Assessors shall minimum have a Technical college degree in a relevant product or medical area, as described below or equivalent.

Appropriate professional areas are listed below as examples.

Non-active devices:

(a) Biology or microbiology;
(b) Biomechanical engineering;
(c) Chemistry or biochemistry;
(d) Dentistry
(e) Human physiology;
(f) Materials or biomaterials science;
(g) Medical technology
(h) Medicine, veterinary medicine;

(i) Nursing
(j) Pharmacy, pharmacology, toxicology;

(k) Physics or biophysics;

(l) Physiology;

• Min. 4 years’ work experience (full time) in the medical device related industry.
• 7+ years of work experience is desirable.
• At least 2 of the 4 years must be in the design, scientific aspects, manufacture, testing or use of the device to be assessed, and/or experience as an assessor in a notified body (full five technical documentation assessments). As part of this work experience, risk management experience should be covered.
• Practical experience in conducting pre-clinical testing or assessing preclinical data with medical devices in one or more of the following areas such as biological safety, physical, chemical and microbiological characterization, stability, shelf life, performance and safety.
• A PhD in a relevant area for medical devices can substitute 3 years of work experience provided that it includes 2 years’ experience in  design, manufacture or testing.
• To be considered for this role, you’ll professional experience in relevant field of healthcare products or related activities e.g.:
  (a) Work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies.
  (b) Work in the application of device technology and its use in health care services and with patients.
  (c) Testing devices for compliance with the relevant national or international standards.
  (d) Conducting performance testing, evaluation studies or clinical trials of devices.

Location:

• Ahmedabad, Gujrat.

In addition to the above you’ll also need to demonstrate the following:

• An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques.
• Work experience in positions with significant QA Regulatory or management systems responsibility.
• Experience with Harmonized medical device standards for active & non active medical devices.
• Experience with Risk Management EN ISO 14971.
• Experience with Sterilization techniques (such as ETO, Gamma, Steam, Dry Heat) and formal qualification desirable.
• Medical device experience from auditing/work.
• Experience auditing against recognized standards.
• Experience of working under own initiative and in planning and prioritizing workloads.
• Solid knowledge of medical devices.
• Should have a flair for technical writing, essential for exhaustive report writing.