ROLE
– Provide Quality and/or Regulatory consulting services, independently or with oversight by a Lead QA/RA Consultant or Consultant Manager
– Leverage regulatory affairs experience gained in the medical device industry/medical device consulting area to provide hands-on support to manufacturers with Quality Assurance and Regulatory compliance requests
– Prepare/review local or international regulatory submissions for or on behalf of manufacturers
– Perform research on regulatory affairs requested for standard or nuanced market environments and generate peer reviewed reports
– Conduct Internal audits / Supplier audits for manufacturers, distributors and vendors
– Maintenance and/or updating of QMS with additional requirements
– Provide Regulatory consulting services, such as research and prepare regulatory classification and strategy / pathway reports
– Review and identify gaps in technical / regulatory documentation
– Prepare premarket submissions to regulatory authorities
– Assist in addressing and responding to deficiencies of product submissions identified by regulatory authorities
– Guidance on testing requirements to support marketing submissions
– Review and advise on labeling and marketing materials, including written documents and website

REQUIREMENTS
– Regulatory affairs experience gained in the medical device industry/medical device consulting area
– Experience with Quality Assurance and Regulatory compliance requests
– Appropriate communication skills
– Knowledge of requirements by market
– Experience with technical documentation files for compliance to applicable regulations
– Medical device industry experience for analysis of existing client QMS against requirements