Head of Regulatory and Affairs

BR23161_1528639109
£8k car, healthcare, pension

Job Details

A leading medical device business based in Cambridgeshire are leading the way in advanced technologies and continuing to expand their facility. The Quality Director has created an opportunity for a Regulatory Affairs and Compliance officer to head a current team. The post offers an incredible salary package with accompanying benefits.

The responsibilities of the head of regulatory and compliance is as follows:

  • Partner with the Director of Quality to align on the strategy for all product(s) and ensure they are consistent with the company (and Group) portfolio strategy
  • Provide critical review and input on device (design) area or portfolio strategies, risk planning and mitigation's
  • Represent the function in senior level interactions at internal governance, technical review committees or steering groups, deputising for the Director of Quality and Regulatory Affairs as required to ensure business (and client) needs are met
  • Work in collaboration with regional policy and intelligence groups to critically analyse the assessment of emerging science/technology, data and changes in the environment and advises senior management on project risks/mitigation activities accordingly
  • Provide effective strategic technical guidance to cross-functional submission teams. This includes overall data interpretation, conclusions, key messages, registration strategy and potential mitigation strategies for risks that may exist

To be a successful head of regulatory and compliance, you will require the following

Strategic leadership skills, with a deep understanding of frameworks, overall device development processes and strategies to influence cross functional discussions with relevant senior internal and external stakeholders

  • Bachelor's degree in life sciences and/or science related field and/or other appropriate knowledge/experience
  • Excellent collaboration, team working, oral and written communication skills
  • Must demonstrate competencies of strategic influencing (of key stakeholders/leaders), innovation, initiative, and leadership
  • Experience in EU & USA Regulatory Filing processes for Medicines and Medical Devices through product life-cycle.

In return you will receive the following benefits package

  • Incredible salary remuneration
  • 20% Bonus (Both company performance & individual objectives achieved)
  • £8k Car Allowance
  • 28 Days holiday Bank Holidays
  • Private Healthcare
  • 8% employer contribution pension
  • Group Life Assurance
  • Employee Share Scheme
  • Active well-being program
  • Continued investment in training and development
  • Free parking
  • On site facilities

We aim to respond to suitable candidates within 5 working days. If you have not heard from us within this time, please feel free to contact us to receive feedback on your application and discuss your requirements.

Professional Technical is acting as an Employment Agency in relation to this vacancy.

 

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