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Regulatory Compliance Specialist

Posted 23 August by Select Appointments Ended

Are you looking to work for a world class organization at the forefront of their industry ?

Are you happy to commit to a six month contract ?

Do you have proven regulatory experience within the Healthcare industry or equivalent ?

Do you have experience in FSCA and FSN reporting ?

If so this could be an excellent opportunity for you…..

This role provides support to the Regulatory Compliance team. You will be responsible for leading the preparation and execution of Field Safety Corrective Action (FSCA) and Field Safety Notice (FSN).

In doing so, you will collaborate with Customer Advocacy, Sales / Marketing, Regulatory Affairs, Manufacturing / Operations, Engineering / R&D, Supply Chain and Services. You will act as liaison with competent authorities for FSCA/FSN matters and ensure complete, accurate and timely submission of FSCA report and responses as required by regulatory agencies.

MAIN ROLE AND RESPONSIBILITIES

Lead the preparation and execution of FSCA/FSN, including

o Raise and complete FSCA strategy and Plan

o Prepare FSN

o Submit completed FSCA strategy, Plan and FSN draft to senior leadership for approval

o Prepare and submit FSCA report to lead Competent Authority

o Obtain traceability reports

o Manipulate data to country level

o Create and distribute country level information

o Generate and progress Change Orders

o Review change order for English FSN and subsequent translations

o Submit FSCA/FSN

o Obtain and provide monthly progression information/data including reconciliation activities and update to Competent Authorities within the required timeframe.

o Respond to additional requests from Regulatory Bodies and internal request.

Support and participate in audits performed by internal and external (e.g. Notified Body) representatives

  • Provide internal support and/or guidance to the business with meeting the regulatory and internal requirements

Competencies

Sound knowledge of International (harmonised) standards in particular: ISO 13485, ISO 14971 and IEC 60601 series;

  • Experience in FSCA and FSN reporting
  • Good numerical, analytic and planning skills, together with the ability to take decisions and to translate those decisions into action.
  • Strong sense of customer focus
  • High level of time management skills to oversee multiple recalls during a period of time.
  • Interpersonal skills with ability to influence others
  • Computer literacy with Microsoft Office packages with a strong working knowledge of Excel and PowerPoint
  • Ability to effectively present information to management, groups and/or customers.
  • Ability to deal with sensitive information in an appropriate and confidential manner

Some travel may be required occasionally, in the UK and abroad

Please note, only successful applicants will be contacted and that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and abilities to perform the duties of the job.

Required skills

  • Regulatory Requirements

Reference: 33146071

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