// February 27th, 2014

Brand New Role! Regulatory Affairs Specialist Required in Hampshire

Regulatory Affairs Specialist Opportunity – Hampshire

Salary up to £45,000 p.a.

Flame Health’s Executive division is currently working with one of the world’s leading manufacturers of soft contact lenses in recruiting for a Regulatory Affairs Specialist for their European Head Quarters in the South of the UK.

The RA Specialist follows the regulatory strategy for assigned corporate projects and writes, files, and obtains approvals for EU and MEA international regulatory submissions.

Responsibilities

  • Writes, files, and obtains approvals for EU and MEA international regulatory submissions
  • Interfaces with project team members, both within the organization and with a diverse range of external groups, to drive corporate initiatives to completion
  • Represents the perspective of regulatory affairs to the company
  • Reviews and approves product labelling and marketing material. Initiates new package inserts and other required product labelling in line with relevant EMEA requirements
  • Supports EMEA “Own Brand” and “Private label “ customers and liaises with EU Competent Authorities and other Ministries of health as necessary
  • In addition to the required technical documentation, supplies samples, packaging, manufacturing site quality system certificates, and certificates of free sale, etc. for global product registrations
  • Keeps abreast of regulatory requirements, this includes monitoring FDA and other agencies regulations and standards
  • Responsible for exhibiting professional behaviour with internal and external business associates that reflects positively on our client, The individual conveys a trustworthy, credible, and reliable image at all times

Knowledge Skills and Abilities

  • Understanding of ISO 13485 requirements and EU medical device regulations
  • Ability to read and understand technical material
  • Excellent attention to detail
  • Excellent organisation skills
  • Excellent written and verbal communication skills
  • Excellent organizational skills
  • Computer literate, with intermediate skill in the use of Word, Excel and Outlook, and some knowledge of relational database systems, e.g. Agile Project Management system
  • Ability to work effectively either alone or as part of a team. Managing time effectively and completing tasks on time with general supervision
  • Experienced at reviewing and approving product advertising and product labelling
  • Flexible and able to self-manage multiple priorities
  • Able to work effectively in multinational/multicultural environments
  • Flexibility to work across the UK sites
  • Full, current driving license

Minimum Experience:

5 years medical device regulatory submission writing; technical writing experience required. Has experience representing regulatory affairs on cross-functional project teams.

Minimum Education:

Bachelors degree in a scientific or technical discipline and working knowledge of medical device regulations.

To apply for this job, or for more information, contact Flame Health Freephone on 0800 085 0858 or if calling from a mobile on 01158 114488 alternatively email careers@flamehealth.com

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