Regulatory Affairs Specialist III

Regulatory Affairs Specialist III

A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

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