Regulatory Affairs Specialist

Job Description

Job Summary:

• The Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on Client regulatory programs.
• The incumbent’s primary responsibilities will be the evaluation, coordination, preparation and implementation of post-market Regulatory Affairs activities.

Duties & Responsibilities:

• Administration of the company’s complaint management program for compliance to corporate requirements.
• Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans.
• Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting.
• Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.
• Additionally, may provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications.
• Functioning as a team expert for promotional materials review, experimental designs, data analysis and product labeling as they relate to registration and commercialization of medical devices.

Required Education:

• Bachelor’s degree in field with 5+ years exp.
• Master’s degree in field with 3+ years exp.

Preferred Qualifications:

• Medical Technologist background strongly desired.
• IVD experience strongly desired.