0800 292 2332
0800 292 2332


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GLOBAL CLINICAL AND REGUALTORY AFFAIRS MANAGER

Salary: 55-74k

Type: Permanent

Conditions: Full Time

Reference: DB4072

Description

LOCATION: UK.

TYPE: PERMANENT.

SALARY: 55-74k.

BONUS: 20%.

 

SUMMARY:

We have an exciting opportunity for a Global Clinical Affairs and Regulatory Manager, to join our international organisation. The successful candidate will be responsible for managing the EC Design Examinations process and ensuring all reviews under 93/42/EEC are technically sound and delivered to a high service standard.

  

ACCOUNTABILITIES:

 

  • Recruitment and training of ECDE reviewers and management of all 93/42/EEC EC Design Examinations;
  • Build the reputation and increase global revenue for EC design Examinations;
  • Support ISMs and sales staff in sales to clients with Class III devices;
  • Develop and promote pre-assessment services package;
  • Line Manager for Global Medical Device Technical Team Leader and Clinician;
  • Ensure competence and regulatory compliance of technical file reviews under 93/42/EEC;
  • Act as an approved signatory for packs and auditor approvals for Class III devices;
  • Act as global product specialist 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.
  • Contribute to improvements in business, procedure and process methods as part of the Global Medical Devices Management team and take specific responsibility for ECDE processes and approvals.


Candidate:

 

The successful candidate will have extensive knowledge of the Medical Device certification business and regulations along with experience in reviewing and auditing working for a Medical Device certification body.

The ideal candidate will have a university degree plus further academic training in a clinically relevant technical subject with experience of high risk Class III devices.

 

KEY WORDS:

CE MARKING / CERTIFICATION / NOTIFIED BODY / REGULATORY AFFAIRS / QA / COMPLIANCE / QC / QUALITY ASSURANCE / CLINICAL / IVD / MDD / MDR / REGULATIONS / SCIENTIFIC / MEDICAL / AFFAIRS / REGULATORY / RA / SUMISSIONS / TECHNICAL / SCIENCE / BIOSCIENCE / BIOMEDICAL / MANAGER / SENIOR / USA / UK / UNITED KINGDOM / LONDON / MILTON KEYNES / BEDFORDSHIRE / MIDLANDS / OXFORD / OXFORDSHIRE / CAMBRIDGESHIRE / SOUTH WEST / SWINDON / WILTSHIRE / GLOUCESTER / GLOUCESTERSHIRE / BRISTOL / SOMERSET / HAMPSHIRE / SURREY / MIDDLESEX / BERKSHIRE / SE LONDON / KENT / SUSSEX / NORTHAMPTON / NORTHAMPTONSHIRE / EAST ANGLIA / SUFFOLK / NORFOLK / ESSEX / CAMBRISGESHIRE / CAMBRIDGE / PETERBOROUGH / BEDFORD / HERTS/ HERTFORDSHIRE / INTERTEK / UL / BUCKS / BUCKINGHAMSHIRE / HEREFORSHRIE / STAFFORD / STAFFORDSHIRE / CHESHIRE / NOTTINGHAM / NOTTINGHMASHIRE / MANCHESTER / M62 / M1 / M25 / M20 / M5 / M6 / LANCASTER / LANCASHIRE / LEEDS / YORK / YORKSHIRE / ENGLAND / WALES / MILTON KEYNES / BEDFORD / BEDFORDSHIRE / NORTHAMPTON / HAMPSHIRE / BASINGSTOKE / SOUTHAMPTON / BRIGHTON / SOUTH EAST / CAMBRIDGE / CAMBRIDGESHIRE / NORFOLK / NORWICH / SUFFOLK / IPSWICH / HAVERHILL / ROMFORD / MIDDLESEX / SLOUGH / WEST SUSSEX / SURREY / MAIDSTONE / DARTFORD / TONBRIDGE / HYTHE / ASHFORD / BIRMINGHAM / LEICESTER / LEICESTERSHIRE / NOTTINGHAM / NEWCASTLE / YORK / GRIMSBY / LINCOLN / LINCOLNSHIRE / WORCESTER / WORCESTERSHIRE / WARWICK / WARWICKSHIRE / HEREFORD / HEREFORDSHIRE / SOMERSET / BATH . Amsterdam, FRANCE, PARIS, MONACO, MONTPELLIER, PERPIGNAN, GRENOBLE, TOULON, TOULOUSE, LYON, DIJON, LILLE, BORDEAUX, ORLEANS LE MANS, NANTES, BREST, RENNES, LIMOGES, GENEVA, EUROPE, BRUSSELS, BELGIUM, RENNES, CAEN, DIJON, MARSEILLE, CLERMONT, LA ROCHELLE, BREST, STRASBOURG, GRENOBLE, LUXEMBORG, GENEVA, CALAIS, AMIENS, VERSAILLES, ORLEANS, BOURGES, LE MANS, LE HARVE, LENS, VANNES, POITIERS, NIORT, MACON, DREUX, EVREUX, BEAUVAIS, COMPIEGNE, CHARTRES, BLOIS, TROYES, FECAMP, SENS / MUNICH, BERLIN, FRANKFURT, DUSSELDORF, MANNHEIM, BREMEN, BONN, HAMBURG, BREMEN, STUTTGART, DORTMUND,LEIPZIG,HANOVER,NURNBERG, LEVERKUSEN, FREIBURG, WOLFSBURG, HOFFENHEIM, AUGSBURG, NURNBERG, WIESBADEN, FURTH, COLOGNE, WURZBURG, Recklinghausen, DARMSTADT / MAINZ / HANAU / RHEIN / KOBLENZ / BUTZBACH / SAARBRUCKEN / METZ / HEIDELBERG / KARLSRUHE / BASEL / ESSEN / MUNSTER / BIELEFELD / LUXEMBURG / BRUNSWICK / WOLFSBURG / DRESDEN / CHEMNITZ / BAMBERG / ULM / ROSENHEIM / AUSTRIA / VEINNA / KOPENHAGEN / STOCKHOLM / ITALY/ROME/MILAN/PALERMO/SAN / MARINO/BOLOGNA/GENOA/MONACO/VENICE/VERONA/TURIN/NAPLES

 

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