Senior Regulatory Affairs Specialist

Company: Real Staffing ( Learn More )

General Information
US-IN-Warsaw
£95,000.00 - £110,000.00 /Year
4 Year Degree
Full-Time
At least 5 year(s)
Not Specified
False
False
Job Description

We currently have an opportunity for a Senior Regulatory Specialist. This position will require leadership and exceptional regulatory experience. Responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers. Interacts with project teams and regulatory agencies in relation to submissions and other relevant topics. The available salary is up to $110,000.

Education:

  • Bachelors Degree, preferably with a Scientific focus
  • Experience:

  • 6+ Years in the RA industry
  • In-depth knowledge of medical device regulations
  • Interaction with health agencies such as the FDA and EU
  • Responsibilities:

  • Manage and build an effective Regulatory team
  • Working effectively in a team environment to ensure not only individual tasks are accomplished, but that team and department objectives are achieved
  • In depth working knowledge of regulations to inform judgments and propose creative solutions
  • Assist with regulatory approval application preparation and submission process
  • Excellent written and verbal communication skills
  • Performs other duties as may be appropriate for this position
  • If you are interested in the position apply directly to Brandon Johnson.

    Sthree US is acting as an Employment Agency in relation to this vacancy.

    Job Requirements