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Regulatory Affairs Manager

Real Staffing
Job LocationManchester
EducationNot Mentioned
Salary£55,000 - £70,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Our client is a fast growing medical device manufacturer with operations in international locations (global business) with locations in UK, China, India, Singapore and most recently the US.They are looking to hire a Regulatory Affairs Manager with expert knowledge of in-vitro Diagnostics (IVDs) medical device industry and of managing and leading regulatory team members.The Regulatory Affairs Manager will help support effective management of the organisations regulatory affairs strategy, in order to support and fulfil the companys global commercial strategy.The role requires management and liaison with the senior management team, internal teams, regulatory authorities and partners.Areas of responsibility:

  • Managing a small RA team covering all areas of regulatory support for the business
  • Lead the creation, management and maintenance of Technical Files/ Medical Device Files for the product range in accordance with the requirements of the IVDD 98/79/EC and MDD Directive 93/42/EC, including CE-marking activities.
  • Manage and lead the IVDR planning transition for the business.
  • Country approvals (e.g. FDA, TGA, HC and ANVISA) and registration processes for worldwide commercial support
  • Lead and support the preparation of regulatory dossiers to support product license applications, import license applications and maintenance of the same for worldwide Regulatory Authorities.
  • The Regulatory Affairs Manager will manage relationships and communications with regulatory agencies and authorised representatives.
  • Maintain a high level of specialist knowledge of the regulatory requirements within each of operational geographical territories.
  • Manage the collation, interpretation and dissemination of specialised regulatory information across the business.
  • Generate the development of the companys regulatory plan, incorporating strategies for the product range in accordance with global requirements.
  • Actively monitor the regulatory environment, assessing the impact of new or changing regulations to the business.
  • The Regulatory Affairs Manager will develop and coordinate transitional plans, as required, to ensure the business continues to operate to current and future regulatory requirements.
  • Provide regulatory direction and support for the product risk management activities and the life cycle of marketed products.
  • Provide regulatory direction and support for post market surveillance, preparing reports for the product range, annually.
  • Oversee the issuance of regulatory compliant product labelling and Instructions For Use documentation, liaising with other departments, including the provision of translations from translation service providers.
  • The Regulatory Affairs Manager will lead and participate in medical device reporting, product recall and withdrawals events, liaising with internal management, regulatory authorities, and partner organisations, as appropriate.
  • Lead the regulatory requirements of the product development process, contributing to product validation plans, reports, claim support papers and other post market activities.
  • Conduct all duties in compliance with GMP, ISO13485, ISO9001, GCP and other regulatory requirements, as identified.
  • Support third party assessments.
  • Consults with all stakeholders (internal and external)
    • Qualifications, Skills and Abilities:
  • Ideally a degree in Life Sciences, ideally in genetics or molecular biology etc.or .
  • Working within the MDD and/or IVDD regulatory affairs arena.
  • Evidenced experience of successfully managing/leading an RA team or members.
  • Knowledge of ISO 13485 and IVD Directive requirements. Knowledge/application/training of the IVD Regulations. Knowledge/application of EU harmonised standards associated with IVDs Proficient in the use of IT tools and systems, including Microsoft Office suite, EDMS software.
  • Excellent communication skills when liaising within the company and with external companies and authorities.
    • Benefits: On offer id an excellent base salary and suite of benefits.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales Required skills
  • Molecular
  • Regulatory Affairs
  • Strategy
  • IVD
  • diagnostic
  • ISO13485
  • licencing
  • Medical Device

    • Keyskills :
    Molecular Regulaty Affairs Strategy IVD diagnostic ISO13485 licencing Medical Device

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