Medical Device Clinical Manager

England Permanent
  • Competitive Salary
  • Flexible Working

About Our Client

A global leader and innovator in inspection, verification, testing and certification services.

Job Description

  • Overseeing the UK Approved Body's processes for Design Examination; Technical Documentation reviews and Vigilance for medical devices , with particular emphasis on Pre-Clinical and Clinical issues.
  • Ensure the effective interaction between Product Assessors, In house Clinicians and Medical Device Technical team to provide an efficient and compliant service to the UK Approved Body and Global Delivering Affiliates.
  • Manage process for Design Examination, in particular clinical aspects, and ensure all reviews under UK conformity assessment scheme, are technically sound and comply with regulatory requirements
  • Ensure the highest level of service is provided to global customers through efficient service delivery and adherence to procedures and processes and to promote the company as the preferred supplier of UKCA Design Examinations.

Key Accountabilities:

  • Act as a UKCA Product Assessor for high risk devices and manage regulatory compliance for implants, biocompatibility, drug/device combinations, sterilisation and clinical evaluations to ensure understanding and compliance throughout and to build up the reputation of the company.
  • Act as line Manager for UKCA Medical Device Clinician (and panel of medical device external clinicians)
  • Support UK Approved Body management on its interactions with clients on the clinical aspects for Class III medical devices (liaising with In-house Clinician as appropriate).
  • Contribute to improvements in business, procedure and process methods in support of the UKCA Medical Devices Certification Manager and take specific responsibility for UKCA Design Examination processes and ensuring suitable competence is maintained.

The Successful Applicant

To be successful in this role, you'll need (extensive and) recent experience

  • Extensive knowledge and experience of the medical device certification business and regulations.
  • Minimum of 4 years relevant medical device industry experience and 2 years (of those 4 years) shall be in the design, manufacture, testing or use of high risk medical devices.
  • Experience of assessment and auditing working for a Medical Device certification body or Approved/Notified Body
  • Experience of working with high risk Class III devices that require the highest level of safety and effectiveness such as surgically invasive implants, contacting CNS or heart, having biological effects or medicinal substance, orthopaedic joint replacements.
  • University degree plus further academic training in a clinically relevant technical subject
  • Demonstrate sufficient knowledge and experience of applying clinical evaluation and PMCF (MEDDEV 2.7, MEDDEV 2.12/2); Clinical investigation design according to ISO 14155; Biocompatibility evaluation according to ISO 10993, Risk Management evaluation according to ISO 14971

What's on Offer

Competitive Salary

Flexible Working

Meg Spillane
Quote job ref
Phone number
+44 207 269 2278

Job summary

Life Sciences
Regulatory Affairs
Healthcare / Pharmaceutical
Contract type
Consultant name
Meg Spillane
Consultant phone
+44 207 269 2278
Job reference