Regulatory Scientist

The Regulatory Scientist develops and prepares technical content of documents related to testing of Class III and higher complexity Class II medical devices submitted to regulatory authorities.

• Must be able to rapidly learn new technical subjects and communicate
technical and scientific information to project teams and regulatory
authorities
• Write clear and accurate descriptions of non-clinical testing and clinical
studies of new medical products that will be used in support of FDA and
Design Dossier submissions
• Review requisite critical data for completeness and suitability for
submission to regulatory authorities domestic and abroad as required
• Maintain knowledge of federal, state and local regulatory requirements
applicable to pre-market submissions for medical devices
• Develop and implement testing and regulatory strategies for new
medical devices
• Assess new technologies for regulatory pathways
• Coordinate with product development, non-clinical and contract research
organizations as needed for meeting project completion target dates

• Collaborate with Global Regulatory Science Director to
achieve appropriate review, technical accuracy and submission quality
as necessary
• Provide leadership/mentoring for Associates and Specialists
• Must work and interact effectively and professionally with and for others
throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral and written communication skills
• Excellent problem solving skills and ability to work in collaborative and
independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations

• Ph.D. in Science or Engineering, or Masters degree with five years
minimum experience with a preferred degree in a Biological Science,
Anatomy or Biomedical Engineering
• Basic understanding of statistical methods and analysis

Physical Requirements:

• Works under general office environmental conditions
• Sitting for extended periods, utilizes close visual acuity for working
with computers, etc.