Regulatory Affairs Specialist

Description:

The Regulatory Affairs Specialist 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 include:

Support continuous improvement activities, including such areas as regulatory procedure development and documentation, aligning and standardizing approach across products and team.


Support regulatory compliance and the development, maintenance and improvement of documentation and processes.


Work closely with regulatory, engineering, marketing, quality and other professionals across the company to support customer inquiries, developing and responding with product compliance documentation.


Work with regulatory colleagues to ensure a consistent and compliant approach is adopted 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), Pharmaceutical Science, Pharmacy OR minimum of 8 years progressive regulatory affairs experience in medical device or pharmaceutical industry

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 or business research.


Excellent verbal and written communication skills with the ability to communicate in English in an easy to understand manner

Education: Bachelors Degree