Regulatory Affairs Specialist III

Regulatory Affairs Specialist III

The Regulatory Affairs Specialist III works with a team of regulatory affairs professionals to ensure the establishment of best practices within the assigned area of responsibility.

Key responsibilities/essential functions:

• Support continuous improvement activities, including such areas as regulatory procedure development and documentation, standards compliance, and metrics development and implementation.
• Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions and post market reporting through the development, maintenance and improvement of documented processes.
• Support regulatory inspections as required
• Work closely with regulatory, engineering, marketing, legal, and other professionals across the company to communicate company-wide programs and processes for regulatory compliance.
• Work with regulatory colleagues to ensure a consistent approach to regulations is adopted throughout the business within areas of responsibility.
• Collect & summarize performance metrics to identify program weaknesses & recommend improvements in procedures or oversight.

Qualifications

Required qualifications:

• Bachelor's Degree (or international equivalent) in a related field such as: Regulatory Science, Biomedical Engineering, Biology, Chemistry, English (with a technical writing emphasis), Legal Studies, Law, Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy OR minimum of 8 years progressive regulatory affairs experience in medical device or pharmaceutical industry or medical product regulation agencies, including knowledge and experience applying drug or device laws and regulations
• 5 years of relevant work experience
• Strong analytical skills
• Ability to work in a team environment with minimal supervision on projects and activities
• Ability to prioritize, plan & evaluate deliverables
• Knowledge & experience conducting scientific, regulatory, legal, or business research.
• Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner
• Experience using spreadsheet and presentation software