Regulatory Affairs Specilaist, Philips Healthcare

Phillips   •  

Gainesville, FL

Industry: Manufacturing / Diversified

  •  

5 - 7 years

Posted 352 days ago

Job Description

Summary Description:  

Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.

Key Areas of Responsibility:   

  • Responsible for the planning, coordination and preparation of document packages for regulatory submissions to the US, EU and/or Canada [e.g. 510(k) Pre-market Notifications, CE Marking, Health Canada].
  • Collaborate with worldwide colleagues regarding license, license renewals and updates
  • Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
  • Communicate application progress to internal stakeholders
  • Maintain regulatory files and tracking databases as required
  • Communicate with regulatory agencies as needed
  • Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways

Minimum Qualifications:

  • Bachelors/Master of Science degree in a software, technical, or biomedical discipline
  • Minimum 6 plus years of experience in medical device regulated environment.  
  • Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide
  • Excellent working knowledge of medical device regulations, FDA law, MDD, other global laws and regulations
  • Experience in supporting international registrations (FDA) and clinical investigations (preference)
  • Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs).  (preference)
  • Knowledge of the SFDA requirements. (preference)
  • Excellent verbal and written communication skills (English)
  • Enthusiastic, self-motivated regulatory professional
  • Good communicator and team player who is able to work in a flexible and goal oriented environment
  • Structured way of working
  • Problem solving and time management skills