job details for:
Assistant Regulatory Affairs Manager In West London

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  Salary :  Competitive  Location : Greater London Map

Flame Health Jobs - Flame Pharma - Medical Devices - Assistant RA Manager/Senior RA Associate - West London

Competitive salary

Flame Pharma is working alongside a global leading eye care Medical Devices organisation, who are looking to recruit an Assistant RA Manager/Senior RA Associate. We are seeking highly driven, organised and capable individuals who thrive in a high-paced and dynamic environment.

The position is based in Greater London and will involve working for the UK’s leading contact lens and contact lens solution manufacturer.

The Role:

  • Review global regulatory requirements for post-market, vigilance, ad recall requirements to ensure compliance for the company and their respective distributors/consultants
  • Liaise with notified bodies and manage own brand label customers, and associated agreements and requirements
  • Work with the Technical projects manager/team to ensure all CE marking technical files are maintained according to the most current regulatory requirements and product ISO standards
  • Manage post-market surveillance activities including customer complaints, recall handling, vigilance reporting and post-market surveillance activities
  • Manage internal audits, regulatory compliance and quality management processes for the technical and regulatory department
  • Manage key regulatory projects and processes in new and existing markets as required
  • Assist with the management of FDA compliance and 510(k) submissions

 The Person:

  • Appreciation of global regulatory requirements for contact lenses, medical devices and working within a regulated industry
  • BSc or equivalent degree in a scientific discipline including but not limited to Biological Sciences, Microbiology, Material Science, Biochemistry, Pharmacy and Physical Sciences/engineering
  • Demonstrated ability to manage, engage and motivate people, set objectives and develop people resources to deliver on key strategic organisational objectives
  • Appreciate the purpose of Quality Management systems for medical device companies such as ISO13485, ISO9001 and other applicable quality management procedures and practises
  • Demonstrated experience of managing the functions of regulatory affairs, product/process development, medical device design and global product registrations

To apply for this job or enquire about additional Pharmaceutical job opportunities in London - contact Flame Pharma Freephone on 0800 085 0858 or if calling from a mobile on 01158 114488 alternatively email careers@flamehealth.com

Flame Health Associates LLP operates as an Employment Agency & Employment Business

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