[Hiring] Technical Specialist & Scheme Manager- General Devices @BSI

Role Description

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

Our Technical Specialists are industry experts that are analytical, communicative, diligent, and always curious. If you are looking for a career change and want to make an impact on patient safety – this may be a great fit for you! This is a home-based position with up to 25% travel.

Essential Responsibilities:

• Deliver Medical Device CE Marking technical reviews under MDD and MDR requirements, scheme management and ISO 13485 QMS assessment services.
• Provide advice and support on certifications in area of expertise that may have a regulatory challenge.
• Participate in client meetings to facilitate CE marking processes.
• Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel.
• Provide “Technical Sales/Networking” support as needed.

Qualifications

• Bachelor's degree or higher in a discipline relevant to medical device design, manufacture and use, or equivalent qualification.
• At least five (5) years' post-graduate experience in the design and development of medical devices in area of experience, including the principles of design control, risk management and performance and/or clinical evaluation.
• Knowledge of medical device regulations.
• Awareness of certification business processes, the application of quality management standards, and audits.

Requirements

• The salary for this position can range from $120,000 to $154,000 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.

Benefits

• Competitive salary.
• Group-sponsored health and dental.
• Short-term and long-term disability.
• Company-matched 401k plan.
• Company paid life insurance.
• 11 paid holidays.
• 4 weeks paid time off.

Company Description

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.