Medical Device Assessors

6 months ago

London, United Kingdom DNV Full time

**About us**:
We 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 world’s 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 SCPA**

We 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 role**:
**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 time frames 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 policies and accreditation/approval requirements.
- Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.

**What we offer**:

- Colleagues with high technical and regulatory skills.
- Work environment with high focus on well-being and high standards for personal and professional development.
- Challenging and attractive position with professional development through work and training.

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**:
Assessor / Auditor shall have a technical college degree in a relevant product or medical area, as described below.

Active devices
- Computer and Software Technology
- Electrical, Electronic, Mechanical or Bioengineering
- Medical Technology

As part of this work experience, risk management experience should be covered:

- Practical experience in conducting pre-clinical testing or assessing pre-clinical 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 it includes 2 years’ experience in design, manufacture or testing.

To be considered for this role, you will have professional experience in a relevant field of healthcare products or related activities, for example:

- Work in medical devices industry or closely related industries (e.g. pharmaceutical industry) in a research and development, manufacturing, quality management or regulatory affairs capacity
- Work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
- Testing devices for compliance in accordance to the relevant national or international standards
- Conducting performance testing, evaluation studies or clinical trials of devices
- Programming (Software) experience would be beneficial

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 prio

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