Medical device technical expert - Contraceptives

TN United Kingdom; United Kingdom; Remote; GBP 50,000 - 80,000; Full time

Job summary

A forward-thinking organization is seeking a Medical Device Technical Specialist with expertise in contraceptives. This exciting home-based role offers the opportunity to deliver CE marking technical reviews and manage ISO 13485 QMS compliance. You will provide regulatory advice and lead client interactions, ensuring high standards in medical device development. With a focus on client-centric and agile behaviors, this position allows for professional growth while making a significant impact in the medical device field. If you have a passion for innovation and collaboration, this role is perfect for you.

Qualifications

• 5+ years experience in designing and developing contraceptive medical devices.
• Strong knowledge of medical device regulations and certification processes.

Responsibilities

• Deliver CE marking technical reviews under MDD and MDR.
• Provide regulatory advice and participate in client meetings.

Skills

Regulatory Compliance

Risk Management

Design Control

Clinical Evaluation

Technical Sales

Education

Bachelor's Degree in Relevant Field

Job description

Medical device technical expert - Contraceptives, home-based, United Kingdom

Join BSI, a leading European Notified Body and ISO 13485-certification organization, as a Medical Device Technical Specialist with expertise in contraceptive devices, including condoms and lubricant gels.

This home-based role involves up to 25% travel (post-COVID-19 restrictions) and requires delivering CE marking technical reviews under MDD and MDR, managing schemes, and assessing ISO 13485 QMS compliance.

You will provide regulatory advice, participate in client meetings, and offer leadership and mentoring in medical device areas. Support may also include technical sales and networking activities.

Qualifications:

• Bachelor's degree or higher in a relevant field or equivalent qualification.
• Minimum of five (5) years post-graduate experience designing and developing contraceptive medical devices, including risk management, design control, and clinical evaluation principles.
• Knowledge of medical device regulations and certification processes.

Advantages:

• Experience with clinical, risk management, biological safety, and validation processes.

We value client-centric, agile, and collaborative behaviors, ensuring a supportive work environment. BSI conducts face-to-face interviews where appropriate, with virtual options available.