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Senior Regulatory Specialist

Senior Regulatory Specialist

  • Location

    City of Edinburgh

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Market related

  • Contact:

    Callum Sparkes

  • Contact email:

    Callum.Sparkes@jcwresourcing.com

  • Contact phone:

    02035899300

  • Job ref:

    LM44259

  • Published:

    about 1 year ago

  • Expiry date:

    2019-09-12

  • Consultant:

    #

Interested in being a senior member of the regulatory function at a global leader in the field of medicla devices? In bringing new and groundbreaking products, while collaborating with some of the world's largest corporations medical functions?

Well a leading medical device company engaged in the design, development, manufacturing and marketing of ultra-widefield retinal imaging devices are offering exactly that!

You'd get the chance to be:

  • Managing and driving regulatory projects, and discussing the strategy with executive management.
  • Provide regulatory expertise in the development and registration of the company's new products.
  • Responsible for driving 510k, CE and other regulatory documentation and submissions.
  • Preparation and Participation in meetings with relevant Competent Authorities.
  • Working with CROs on paths to market for new technologies through extensive research.
  • Communicate effectively with external and internal parties, building strong relationships.
  • Keeping the business up to date with the latest developments in global regulations.
  • Provide regulatory guidance in the development and validation of new and existing products.
  • Advise clients on regulatory strategy plans for assigned projects.

What experience will serve you best in your application:

  • At least 5 years' experience within the Medical Devices industry in a technical or regulatory position.
  • Previous exposure to the US regulations, previously submitting 510(k)s, PMAs (Desirable), and attending FDA meetings.
  • Degree (or equivalent) in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences.
  • Knowledge of cGMP / Quality System Regulations is essential.
  • Fluent English both written and oral is essential.

Desirable:

  • Excellent practical experience of regulatory submissions and requirements.
  • Widespread experience in the highly regulated medical device market.
  • Good awareness of FDA & MHRA systems and procedures.
  • Direct experience with Medical Device approvals, specifically with clinical trial requirements.
  • Excellent presentation skills are required.