UKCA Medical Device Clinical Manager

Job content

Job Title:UKCA Medical Device Clinical Manager

Job Type:Permanent

Hours: 37.5 per week

Job Location:Station Road, Oldbury, B69 4LN

Salary: As a UKCA Medical Device Clinical Manager, you’ll receive a salary of between £60,000 and £80,000, depending on experience, plus you’ll benefit from a 20% performance bonus private health cover, a contributory pension scheme and life cover.

As the UKCA Medical Device Clinical Manager you’ll be responsible for:

• 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 AB0120 Medical Device Technical team to provide an efficient and compliant service to the UK Approved Body and Global Delivering Affiliates.
• Manage SGS’s process for Design Examination, in particular clinical aspects, and ensure all reviews under UK conformity assessment scheme, (UKCA) are technically sound and comply with regulatory requirements UK MDR 2002 (as amended).
• Ensure the highest level of service is provided to global customers through efficient service delivery and adherence to SGS procedures and processes and to promote SGS 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 SGS and to build up the reputation of SGS.
• 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..

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

In addition to the above you’ll also need to demonstrate the following;

• Fluent in English
• Ability to represent SGS to medical device regulatory authorities
• Ability to understand customer and market expectations and to be customer focused
• Excellent technical competency and understanding of medical device technologies and regulations
• Excellent interpersonal and communication skills (highly developed presentation skills)
• Negotiation and persuasion and change management skills.

APPLY NOW for full consideration, you can be sure that your application will be treated confidentially and impartially, and you will always receive an update within 10 business days.