Clinical Evaluation Specialist - Active Devices, The British Standards Institution (BSI), Reston, VA
The British Standards Institution (BSI) -
Reston, VA,
US
Clinical Evaluation Specialist - Active Devices
Date Posted: 2024-04-23
Job description
Great that you're thinking about a career with BSI!
This is an excellent opportunity to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients across Europe, and to be involved in the evaluation of cutting-edge innovation and state of the art technologies.
This role offers real diversity and variety carrying out detailed assessments of clinical evaluation reports to ensure that active medical devices and their accessories meet the safety and performance requirements of the regulations regarding clinical data including:
Responsibilities:
You will be responsible for ensuring that the clinical aspects of Technical Documentation Reviews are completed on time, interfacing with medical device manufacturers as needed. You'll also work with our Internal Clinicians to ensure that the relevant External Clinical Experts and Clinical Statisticians are engaged in the clinical assessment process as well as ensuring that the clinical requirements of the Medical Device Regulations are being met. You'll be interacting with a variety of medical device professionals, such as our Technical Specialists and Scheme Managers, to determine the clinical impact of design changes and determine the level of clinical assessment required.
To be successful in the role, you will have:
Desirable Skills / Background
What we offer:
The salary for this position can range from $113,500 to $140,000 annually plus 10% bonus; actual compensation is based on various factors, including but not limited to, the candidate's competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons.
BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.
Do you believe the world deserves excellence?
We are proud to be the business improvement company for other organisations to become more sustainable and resilient and finally to inspire trust in their products, systems, services, and the world we live in.
Headquartered in London, BSI is the world's first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries, offering development, auditing, certification, and training services, including innovative software solutions and cyber security expertise for all industries: from aerospace and automotive to food, construction, energy, healthcare, IT and trade sectors. Incorporated by Royal Charter, we're truly impartial, and home to the ultimate mark of trust, the Kitemark.
Through our unique combination of consulting, training, assurance and regulatory services we bring solid and broad knowledge to every company.
If you want to contribute to this inspiring challenge, bring your open and enthusiastic mindset to our dynamic team, apply now and become part of the BSI family!
D&I Policy
BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. BSI is a community where everyone can thrive.
If you require any reasonable accommodations to be made on account of a disability or impairment throughout out our recruiting process, please inform your Talent Acquisition Partner.
#LI-SC2
#LI-REMOTE
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is an Equal Opportunity Employer and we are committed to diversity.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
This is an excellent opportunity to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients across Europe, and to be involved in the evaluation of cutting-edge innovation and state of the art technologies.
This role offers real diversity and variety carrying out detailed assessments of clinical evaluation reports to ensure that active medical devices and their accessories meet the safety and performance requirements of the regulations regarding clinical data including:
- Clinical evaluation reports
- Clinical strategy documents
- Clinical investigation protocol and results
- Published clinical literature
- Post market clinical follow-up (PMCF) protocol and results
- Post market surveillance data including vigilance reports, Risk management documentation, Periodic summary update reports (PSUR)
- Summary of Safety and Clinical Performance (SSCP) reports
- Instructions for use (intended use, contraindications, warnings and precautions)
- Risk analyses
- Relevant pre-clinical testing such as animal study test protocols and results
- First in man protocols and test results
Responsibilities:
You will be responsible for ensuring that the clinical aspects of Technical Documentation Reviews are completed on time, interfacing with medical device manufacturers as needed. You'll also work with our Internal Clinicians to ensure that the relevant External Clinical Experts and Clinical Statisticians are engaged in the clinical assessment process as well as ensuring that the clinical requirements of the Medical Device Regulations are being met. You'll be interacting with a variety of medical device professionals, such as our Technical Specialists and Scheme Managers, to determine the clinical impact of design changes and determine the level of clinical assessment required.
To be successful in the role, you will have:
- Bachelor's or postgraduate degree in a discipline relevant to medical device research and development and/ or use (e.g., engineering, medicine, nursing etc.), or equivalent qualification.
- Excellent analytical, critical thinking, and scientific reading and writing skills
- Experience in risk management and in particular in the assessment of clinical data to support a benefit vs risk argument, as well as involvement in clinical trials, including providing clinical support to physicians and surgeons.
- Experience with active medical devices such as:
- Active imaging devices
- Active devices for monitoring and/or diagnosis
- Active devices utilising radiation
- Active devices for hyperthermia/ hypothermia
- Active devices for shock-wave therapy (lithotripsy)
- Active devices for stimulation or inhibition
- Active respiratory and infusion devices
- High frequency surgical or ablation devices
- Software as a Medical Device (including Artificial Intelligence)
Desirable Skills / Background
- Thorough knowledge of the design, development, and implementation of clinical trials, scientific research or scientific writing
- Active medical device design or engineering background
- Working knowledge of ISO 14155 Clinical investigation for medical devices for human subjects - Good clinical practice
- Working knowledge of MEDDEV 2.7/1, Rev 4, Clinical evaluation: a guide for manufacturers and notified bodies under directive 93/42/EEC and 90/385/EEC; MDR EU 2017/745; and clinical MDCG guidances such as MDCG 2020-6
- Background in clinical epidemiology or clinical statistics
What we offer:
The salary for this position can range from $113,500 to $140,000 annually plus 10% bonus; actual compensation is based on various factors, including but not limited to, the candidate's competencies, level of experience, education, location, divisional budget and internal peer compensation comparisons.
BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company paid life insurance, 11 paid holidays and 4 weeks paid time off.
Do you believe the world deserves excellence?
We are proud to be the business improvement company for other organisations to become more sustainable and resilient and finally to inspire trust in their products, systems, services, and the world we live in.
Headquartered in London, BSI is the world's first national standards organization with more than 100 years of experience. We are a global partner for 86,000 companies and organizations in over 193 countries, offering development, auditing, certification, and training services, including innovative software solutions and cyber security expertise for all industries: from aerospace and automotive to food, construction, energy, healthcare, IT and trade sectors. Incorporated by Royal Charter, we're truly impartial, and home to the ultimate mark of trust, the Kitemark.
Through our unique combination of consulting, training, assurance and regulatory services we bring solid and broad knowledge to every company.
If you want to contribute to this inspiring challenge, bring your open and enthusiastic mindset to our dynamic team, apply now and become part of the BSI family!
D&I Policy
BSI is committed to ensuring the diversity of our workforce reflects that of our clients and the communities in which we operate. Our goal is to create a sense of belonging for all employees by providing opportunities to develop, grow, and engage with our global organization all while having fun doing great work. BSI is a community where everyone can thrive.
If you require any reasonable accommodations to be made on account of a disability or impairment throughout out our recruiting process, please inform your Talent Acquisition Partner.
#LI-SC2
#LI-REMOTE
Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is an Equal Opportunity Employer and we are committed to diversity.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.