Regulatory medical device Work, Jobs in Remote (with Salaries)

Technical Specialist - Active Medical Devices
BSI —Remote
- £58,500 - £78,000 a year
- Remote
- English
- Project management
- Bachelor's degree
- Flexible schedule
Principal Medical Writer - Publications
Syneos - Clinical and Corporate - Prod —Remote
- Full-time
- Remote
- English
- Travel
- Contracts
3d
Head of Regulatory Affairs (Chorley - Remote/ Hybrid)
Vernacare International Ltd —Remote
- Remote
- Leadership
- Communication skills
- Annual leave
- Employee assistance programme
Quick apply
9d
Regulatory Consultant - CMC (CMC with small molecule products)
サイネオス・ヘルス —Remote
- Remote
- Bachelor's degree
- Contracts
Principal Medical Writer - Publications
サイネオス・ヘルス —Remote
- Remote
- English
- Travel
- Contracts
3d
Biomedical Engineer- Site Based
GE HEALTHCARE —Remote
- Hospital
- Engineering
- Microsoft Office
Regulatory Affairs Manager - Regulatory Liaison - FSP
Thermo Fisher Scientific —Remote
- Full-time
- Remote
- English
- Microsoft Office
- Master's degree
4d
Validation Specialist - 12 Month FTC
Watson-Marlow Fluid Technology Solutions —Remote
- £50,000 a year
- Remote
- Engineering
- No degree
- Annual leave
- Employee assistance programme
10d
Senior Specialist, Evidence Evaluation
Smith & Nephew —Field Based
- Full-time
- Hybrid work
- Annual leave
- Employee discount
Application Architect, Medical Imaging
Perceptive —Remote
- Full-time
- Remote
- Doctoral degree
- Computer Science
- DevOps
Senior Product Manager, Medical Imaging
Perceptive —Remote
- Full-time
- Remote
- Azure
- English
- Business development
Per Diem Research Nurse London UK
サイネオス・ヘルス —Remote
- Remote
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Outlook
3d
Clinical Sales Specialist
Sol-Millennium Medical —Remote
- Full-time
- Remote
- Nursing
- Sales
- Analysis skills
Quick apply
Business Analyst
AARK TECH SOLUTIONS GmbH —Remote
- Remote
- Azure
- Analysis skills
- APIs
Service - Field Service Engineer (FSE) – Magnetic Resonance Imaging (MRI) / X-Ray (XR) - London
GE HEALTHCARE —Remote
- CRM software
- Engineering
- English
Consultant - Veeva PromoMats
Veeva Systems —Remote
- Full-time
- Remote
- CRM software
- PMP
- English
- Work from home
Executive Director, General Partner (Biopharma Account Lead)
Thermo Fisher Scientific —Remote
- Full-time
- Remote
- Master's degree
- Analysis skills
- Bachelor's degree
Channel Manager-Southern Europe/Northern Africa/Brazil
OraSure Technologies Inc. —Remote
- £53,000 - £80,000 a year
- Full-time
- Remote
- Sales
- Business development
- Bachelor's degree
- Annual leave
- Employee assistance programme
Quick apply
EU Business Development Director - Commercial Leadership | GMP Labs
Thermo Fisher Scientific —Remote
- 8 hour shift
- Remote
- Sales
- Microsoft Office
- Master's degree
8d
Senior Consultant - Vault PromoMats
Veeva Systems —Remote
- Full-time
- Remote
- Spanish
- PMP
- Salesforce
- Work from home

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Technical Specialist - Active Medical Devices

BSI -
Remote

Apply Now

Job details

£58,500 - £78,000 a year

Benefits

Flexible schedule

Qualifications

English
Project management
Bachelor's degree
Mentoring
Leadership
Communication skills

Full job description

We exist to create positive change for people and the planet. Join us and make a difference too!

Job title: Technical Specialist & Scheme Manager - Active Devices

Location: Global Homebased

BSI is seeking experienced medical device professionals to join our Active Medical Devices team as a home-based Technical Specialist and Certification Scheme Manager (Final Reviewer). If you have hands-on experience in the research, design, manufacture or testing of active devices we'd love to hear from you.

As a Technical Reviewer, you will work with medical device manufacturers throughout their certification life cycle to place active medical devices on the European market. This position applies a mix of engineering and design knowledge, newfound regulatory expertise, English writing skills, client and project management. You will assess cutting edge technology that will make a difference in patient health and safety and broaden your technical knowledge through ongoing training.

Responsibilities:

Review and evaluate medical device technical and clinical documentation in your areas of competence to assess compliance with MDD 93/42/EEC, MDR 2017/745 and UK MDR 2012 schemes.
Manage certification activities for a portfolio of medical device manufacturers, including determination of auditing requirements and making recommendations for the issue and maintenance of CE certifications.
Provide specialist regulatory, operational and strategic support to medical device scheme managers, products specialists and the business in the delivery of CE medical device marking schemes.
Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel.

To be successful in this role, you will have:

Four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
Bachelor’s or higher degree in a discipline relevant to the medical device industry. This may include electronic/electrical, electro-mechanical or biomedical engineering or medical physics.
Familiarity with the Medical Devices Regulation (EU)2017/745 and/ or Medical Devices Directive 96/42/EEC is an advantage.
At minimum, an awareness of the requirements of IEC 60601 family of standards and the risk management standard ISO 14971.
Understanding of the principles of design control and risk management.
Strong interpersonal communication skills.
Ability of prioritizing and executing individual workload.
Candidates with professional experience gained in accredited testing laboratories and a broad exposure to a range of active medical devices have been successful in the role.

Interested? To apply for this role please submit your application today and take the next step in your career as a Technical Reviewer with BSI.

BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development. The salary for this position for the UK can range from £58,500- £78,000 annually; 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. If you are based in the EU, your recruiter can inform you of the local salary banding which differs per country based on various factors.

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-REMOTE

#LI-SC2

About Us

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.

Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.

Apply Now

Refine Your Search

regulatory medical device jobs in remote

Technical Specialist - Active Medical Devices

Principal Medical Writer - Publications

Head of Regulatory Affairs (Chorley - Remote/ Hybrid)

Regulatory Consultant - CMC (CMC with small molecule products)

Principal Medical Writer - Publications

Biomedical Engineer- Site Based

Regulatory Affairs Manager - Regulatory Liaison - FSP

Validation Specialist - 12 Month FTC

Senior Specialist, Evidence Evaluation

Application Architect, Medical Imaging

Senior Product Manager, Medical Imaging

Per Diem Research Nurse London UK

Clinical Sales Specialist

Business Analyst

Service - Field Service Engineer (FSE) – Magnetic Resonance Imaging (MRI) / X-Ray (XR) - London

Consultant - Veeva PromoMats

Executive Director, General Partner (Biopharma Account Lead)

Channel Manager-Southern Europe/Northern Africa/Brazil

EU Business Development Director - Commercial Leadership | GMP Labs

Senior Consultant - Vault PromoMats

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