Medical device technical expert - Contraceptives

TN Germany; Deutschland; Remote; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading company in medical device certification is seeking a Medical Device Technical Specialist with expertise in contraceptives. This home-based role involves CE marking technical reviews and supporting clients through regulatory processes. Ideal candidates will have a strong background in medical device design and regulations, with at least five years of relevant experience.

Qualifikationen

• At least five (5) years of post-graduate experience in contraceptive medical devices.
• Knowledge of medical device regulations.
• Awareness of certification business processes and quality management standards.

Aufgaben

• Deliver Medical Device CE Marking technical reviews under MDD and MDR requirements.
• Provide advice on certifications facing regulatory challenges.
• Participate in client meetings to facilitate CE marking processes.

Kenntnisse

Analytical

Communicative

Diligent

Curious

Ausbildung

Bachelor's degree or higher in a relevant discipline

Jobbeschreibung

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.

BSI is a designated European Notified Body, an accredited ISO 13485-certification body, a recognized Auditing Organization under MDSAP, and we have an opportunity for you to join our growing team!

We are seeking a Medical Device Technical Specialist with contraceptives expertise, including condoms and lubricant gel related medical devices.

Our Technical Specialists are industry experts who 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).

Responsibilities include:

1. Deliver Medical Device CE Marking technical reviews under MDD and MDR requirements, scheme management, and ISO 13485 QMS assessment services.
2. Provide advice and support on certifications in your area of expertise that may have regulatory challenges.
3. Participate in client meetings to facilitate CE marking processes.
4. Provide Medical Device expertise leadership and mentoring in your areas of competence to medical devices personnel.
5. Support technical sales and networking activities 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 an equivalent qualification.
• At least five (5) years of post-graduate experience in the design and development of contraceptive medical devices/products, including principles of design control, risk management, and performance and/or clinical evaluation.
• Knowledge of medical device regulations.
• Awareness of certification business processes, application of quality management standards, and audits.

Advantages:

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

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These behaviours define how we operate at BSI, ensuring a great workplace and business success.

BSI is conducting face-to-face interviews where appropriate and possible. If invited to an interview but prefer virtual, please discuss this with our recruitment team.