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Regulatory Affairs Group Manager - Licensing (M/F)

HAYS

01.07.2022 | Porto | Referência: 2044880


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Hays
Regulatory Affairs Group Manager - Licensing (M/F)

Porto



A empresa onde vai trabalhar




The Group Manager, Regulatory Affairs - Licensing, is responsible for the operation of the Regulatory Affairs - Licensing Department. The position oversees facility licensing and certification activities for all company, ensuring that licenses and certificates are obtained and renewed within required time frames. In addition, the Group Manager, Regulatory Affairs - Licensing, interacts with internal customers at headquarters, laboratories, and radiology centers to ensure that licensing and certification needs are met in support of company objectives and regulatory compliance.



A sua nova função





  • Responsible for the operation of the Regulatory Affairs - Licensing Department

  • Assign work, monitor progress and quality of work so that work is equitably and appropriately assigned, and deadlines are met with high quality work

  • Oversee facility licensing and certification activities for all companies of the group, ensuring that licenses and certificates are obtained and renewed within required time frames

  • Develop and monitor systems to ensure the efficient and effective operation of the department

  • Interact with internal customers at headquarters, laboratories, and radiology centers to ensure that licensing and certification needs are met in support of company objectives and regulatory compliance

  • Ensure files of all correspondence and communications with regulatory agencies are maintained and properly archived

  • Monitor and communicate changes in regulatory requirements

  • Prepare Group SOPs and train staff as required




O que necessita para ser bem sucedido





  • Solid interpersonal skills and relationship management

  • Ability to clearly communicate verbally and in writing with external contacts that may include, lawyers, regulatory authorities, as well as internal customers at headquarters and in the countries

    • Ability to interpret and effectively communicate regulatory requirements

    • Ability to work independently and initiate contacts as necessary

    • Able to work effectively under pressure and to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives





  • Bachelor’s Degree in a Relevant Discipline PLUS 5 years of related technical and / or Regulatory experience in the Healthcare industry, preferably in the clinical laboratory industry.

  • English fluent as a must (presenting, writing, reading). Minimum Years Recommended and/or Preferred: 5-7 years




O que a empresa lhe pode oferecer




Be part of a good company in the industry;

Good salary package;

Possibility to grow.



Próximo passo

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Caso não seja bem isto que procura, contacte-nos para falar sobre outras oportunidades de carreira, sempre de forma absolutamente confidencial.

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