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.
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
- 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
Thanks
Warm regards
Avleen Kaur
732-318-6945
