Product Specialist Medical Device/IVD Hyper Recruitment Solutions are currently looking for a Product Specialist Medical Device/IVD to join a leading Notified Body. As the Product Speciali... View Job
CSV and Data Integrity Manager Do you have extensive knowledge of regulatory expectation for Data Management and the drive and interpersonal skills required to deliver on business w... View Job
Field Service Engineer Field Service Engineer£32,000 - £36,000 + £4k Car Allowance, £1k Lunch Allowance & a bonus of £600pmWe are currently looking for a Field Service Engin... View Job
are currently looking for a Global Clinical Affairs and Regulatory Manager to join a leading Notified Body. As the Global Clinical Affairs and Regulatory Manager you will be responsible for playing a key role in managing Global Medical Devices certification under 93/42/EEC, with a focus on Clinical/Pre-Clinical issues.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Global Clinical Affairs and Regulatory Manager will be varied however the key duties and responsibilities are as follows:
1. You will manage the Design Examinations process reviewing all relevant documentation (EC Design Examinations and Technical Files) under 93/42/EEC. This will involve the recruitment and training of a team of Technical Specialists, as well as performing line management duties.
2. The Global Clinical Affairs and Regulatory Manager will ensure all technical file reviews maintain compliance to 93/42/EEC, as well as acting as a global product specialist and approved signatory ensuring regulatory compliance for high risk Class III Medical Devices.
3. You will provide Subject Matter Expertise throughout the Notified Body on multiple area's including Bio-compatibility, drug/device combinations, sterilisation and clinical evaluations. It will be your responsibility to ensure compliance throughout the business and enhance the reputation of the notified body.
4. Supporting the interaction with a variety of Third Parties including clients on the clinical aspects of Class III Medical Device development. This will include approving an audit schedule and maintaining current and expert knowledge of relevant regulatory guidelines.
To be successful in your application to this exciting opportunity as the Global Clinical Affairs and Regulatory Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Scientific Discipline combined with expert knowledge on the Clinical Development of Medical Devices.
2. Proven industry experience in Clinical/Regulatory Affairs within an environment manufacturing a High Risk/Class III Medical Device.
3. A working knowledge and practical experience with the assessment/auditing aspect of a Medical Device Certification Body.
Key Words: Medical Device | ISO13485 | Med Devices | Clinical Affairs | IVD | Technical Files | Audit | Auditor | 93/42/EEC | EC Design Examinations | Class III | Class 3 | Research and Development | Clinical Trials | In-Vitro Diagnostics | Notified Body | Certification | GMP | GCP | GXP | Technical Specialists | Technical Assessors
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.