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Senior Regulatory Affairs Officer

  • Location:

    Sunderland, United Kingdom

  • Contact:

    Nathan McGarry

  • Job ref:

    4330

  • Published:

    about 1 month ago

  • Expiry date:

    2021-06-11

Are you a Regulatory Affairs Officer looking for an exciting new opportunity to work on site or remotely? Do you want to work for a large Medical/Pharmaceutical company that make a real difference in the world? Would you be interested in working in an environment where you are valued and offered progression? Are you looking to work in a state-of-the-art facility? If so this may be the opportunity that you have been searching for…

The responsibilities of the Senior Regulatory Affairs Officer will be as follows:

  • Serve as Regulatory Affairs representative on new product development teams and external partnership programs.
  • Collaborate globally and cross-functionally (e.g., Global Clinical Affairs, Business Development, Quality Assurance, Research & Development, Product/Program Management) to define regulatory strategy and plans for clearance / approval of the company’s products.
  • Align with external partners and stakeholders on study designs, submissions etc., and participate in relevant meetings.
  • Author and maintain regulatory submissions including defining the global regulatory requirements, creating standard work and action plans, optimizing timelines, articulating submission content and format and developing countermeasures as plans evolve.
  • Communicate and negotiate with global regulatory agencies to meet business goals and regulatory milestones for product commercialization.

What you will need to do the job:

  • Bachelor’s degree in science or engineering or equivalent experience.
  • Ideally have training/knowledge in IVD or medical device Regulatory Affairs.
  • Experience in supporting New Product Development for high complexity products.
  • Any experience supporting clinical trials is advantageous.
  • Proven experience with regulatory strategy and submissions for high-complexity diagnostic products in a global market.
  • Experience in the IVD, Companion Diagnostics and/or stand-alone software/digital fields preferred.
  • Experience in mentoring
  • ISO13485 Experience is Essential

The successful Senior Regulatory Affairs Officer will be offered the opportunity to join an Organisation that are having an extremely successful period in the industry and you will drive improvement across the facility. Therefore, if you are a Regulatory Affairs professional that is looking for a dynamic, fast-paced environment, who would thrive in an organisation that has a genuine appetite for continuous improvement please get in touch.