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Senior Regulatory Affairs Consultant

Huxley
San Diego, CA Full Time
POSTED ON 3/6/2025
AVAILABLE BEFORE 6/5/2025

Title : Seeking a Senior Regulatory Affairs Consultant for Medical Devices in San Diego

Introductory Paragraph :

We are currently seeking an experienced and highly qualified Senior Regulatory Affairs Consultant to join our client's team. The role is based in the beautiful city of San Diego, where you will work on exciting projects related to medical devices.

Responsibilities :

As a senior regulatory affairs consultant, your responsibilities would include but not limited to :

  • Developing global regulatory strategies
  • Preparing submissions (i.e., 510(k), PMA)
  • Interacting with agencies such as FDA or Health Canada
  • Reviewing labelling and promotional materials
  • Conducting risk assessments

Qualifications & Skills Required :

  • The successful candidate should have experience working within the healthcare industry specifically dealing with medical device regulations. Some key qualifications required for this position includes;
  • Education :

    A bachelor's degree preferably scientific discipline eg biology / biochemistry / chemical sciences / pharmacology etc.

    Experience :

  • Minimum of 5 years' experience as a regulatory professional within medical devices sector;
  • Demonstrable expertise preparing US pre-market submission including PMAs;
  • Expertise interpreting standards / guidance documents from governing bodies like FDA / Health Canada ;
  • Strong communication skills both written and verbal ; comfortable presenting at meetings either internally or externally ;
  • Rate & Contract Type :

    This job offers £600 per day rate , dependent upon relevant experiences . This opportunity also provides flexibility by offering contract-based employment which allows consultants who prefer project-based arrangements rather than long-term commitments .

    If you possess these qualifications / skills combined with excellent problem-solving abilities then we encourage you apply today!

    Salary : $600

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