Job Description Summary

We have an excellent new opportunity for a Medical Device Lead Auditor to join our global organization. The successful candidate will be responsible for planning, conducting and leading clinical audits for in vitro diagnostic medical devices and in vivo medical devices, in accordance with 21 CFR Parts 50, 54, 56, 812, ISO14155, ISO 20916, EU-MDR 2017/745 and EU-IVDR 2017/746 regulations and standards, enabling the delivery of assessments that meet customer requirements and appropriate standards.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find ground-breaking solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

We have an excellent new opportunity for a Medical Device Lead Auditor to join our global organization. The successful candidate will be responsible for planning, conducting and leading clinical audits for in vitro diagnostic medical devices and in vivo medical devices, in accordance with 21 CFR Parts 50, 54, 56, 812, ISO14155, ISO 20916, EU-MDR 2017/745 and EU-IVDR 2017/746 regulations and standards, enabling the delivery of assessments that meet customer requirements and appropriate standards.

• Plan, conduct, and lead complex clinical study audits (Sponsor, Investigator Sites and Clinical Suppliers) (either remote or on site) in accordance with all applicable regulations, standards, guidance, and the established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.

• Complete audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of in vivo medical devices and in vitro diagnostic devices' application.

• Manage audit observations and audit reports through the internal audit database and CAPA process.

• Work with the business units/auditees to develop appropriate actions, provide recommendations, and ensure that the corrections/corrective actions are appropriate and effective.

• Coordinate timely closure of actions.

• Escalate issues to management and/or the business unit, if needed.

• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.

• Project manage auditing teams, as appropriate, to improve efficiencies, enhance client satisfaction and ensure compliance with standards.

Qualifications

To be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:

• Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.

• Minimum 2 years of relevant professional experience shall be in clinical auditing.

• Extensive knowledge of ISO 20916:2019, EU IVDR 2017/746, ISO 14155:2020, EU-MDR 2017/745, 21 CFR Parts 50, 54, 56 and 812

• Work experience in positions with significant QA, Regulatory or management systems responsibility.

• Medical device experience from auditing/quality

• Experience auditing against recognized standards.  

• Experience of working under own initiative and in planning and prioritizing workloads  

• University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Mechanical, Electrical or Electronic Engineering, Computer & Software Technology, Human Physiology, Nursing, Quality Management.

Other

• Work remotely

• Around 25% travel

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.