Regulatory Affairs Specialist Senior
Covidien - Tampa, FL

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Are you Covidien?

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. We deliver outstanding results and innovative solutions in the Medical Device and Medical Supplies segments. Through progressive thinking and cutting-edge technologies, Covidien is well positioned to lead the way in today’s rapidly changing healthcare industry. Whatever your specialty or ambitions, you can make a difference at Covidien – both in the lives of others and your career.

At Covidien, we strive to fully understand our marketplace, customers, communities and employees, and we enter into relationships with a sense of honesty, fairness and trust.

We are an affirmative action/equal opportunity employer.

SENIOR REGULATORY AFFAIRS SPECIALIST :

The Senior Regulatory Affairs Specialist works on a cross-functional team to partnerin support of product registrations and support of Regulatory activities including but not limited to:

ESSENTIAL FUNCTIONS :
  • Organization and preparation of final regulatory filings (e.g. product submissions and site/establishment registrations)
  • Under direction, review change control documents and ascertain regulatory impact
  • Collaborate with internal Covidien departments to develop test protocols and regulatory strategy
  • Act as liaison with International Covidien Regulatory Personnel to address questions and issues that arise as part of the registration process
  • Establish and maintain a professional and credible image with regulatory agencies
  • Maintains and updates Regulatory databases for tracking submissions and issues
  • Understand and recommend strategies based on current local registration requirements and applicable industry standards
  • Maintain knowledge of competitive technologies in addition to medical and technical developments related to the company’s products
  • Understand local country quality requirements (e;g. ISO, QSR)

Requirement s:

Education: Bachelors Degree required - Engineering or Biotechnology major preferred

Experience:

5-8 Years of Regulatory experience required - medical device experience strongly preferred.

Demonstrated knowledge of Good Manufacturing Practices (GMP) and applicable Quality standards.

Previous knowledge with Process Validation

Skills/Competencies:
  • Strong organizational skills
  • Ability to problem solve
  • Ability to work well with others
  • Team Oriented
  • Excellent written and oral communication skills
  • Fluent in local language required

Covidien - 6 months ago - save job - block
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Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers...