Medical device technical expert - Contraceptives

7 months ago 3 Applied
Job Description

Great that you're thinking about a career with BSI!
Excited to grow your career
Our people make all the difference in our success.
We are seeking a Medical Device Technical Specialist with contraceptives expertise to include gloves ,condoms and Lubricant gel related medical devices.

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 (when COVID-19 travel restrictions lift).
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

The ideal candidate will possess the following characteristics:

  • Bachelor's degree or higher in a discipline relevant to medical device design, manufacture and use, or equivalent qualification.

  • At least five (8) years post-graduate experience in the design and development of gloves and contraceptive medical devices/products, 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.

  • Exposure to clinical, risk management, biological safety and validation.

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.




Job Source:

BSI continues to support our people and clients to make a difference during this challenging time. Our focus on Innovation in the way we support the COVID 19 effort, continue to deliver to clients and adapt through agile working methodologies are helping us navigate these unique times. We are still recruiting especially in areas that are Client facing and Business Development , and you can find vacancies advertised on Workday - Career - Find Jobs. We are conducting Virtual Interviews and Inductions, it's amazing how positively people are embracing new ways of working and staying connected. Stay safe. Our ambition is to be recognized and valued globally as a best-in-class company a client-driven, efficiently-run, growing business. BSI has come a long way since being founded in 1901. Today, we're a global business services organization, respected world over for the development of standards assessment of management systems testing and certification of products and services providing software solutions and the delivery of training courses. We offer diverse career paths from auditing to sales, product development to finance, and from IT to marketing.

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