Regulatory Affairs Specialist

Job title: Regulatory Affairs Specialist

12 months contract

Working without significant direction, assists in fulfilling Regulatory compliance requirements by applying a thorough understanding of regulatory standards to one or more areas of expertise such as regulations for medical devices.

Essential duties

• Using a broad base of knowledge and understanding of regulatory requirements in Russia and the EAEU counties, assumes major responsibility for one or more major regulatory affairs areas
• Interacts with regulatory consultants and authorized representative in Russia and EAEU member states. Interacts with and/or directs others in interacting with regulatory and certification authorities;
• Identifies and defines contents for regulatory filings/dossiers. Leads the assembly and creation of these documents for their timely submission to regulatory authorities, ensures documentation is compliant for submission to the referent state/member states;
• Ensures labeling compliance to the EAEU requirements;
• Maintenance of sometimes complex existing licenses/certificates, product approvals and simple post market notifications;
• Responsible for overall compliance with regulatory requirements that apply to the product development cycle. Makes recommendations on how to achieve compliance.
• Works with manufacturing, engineering, and other functional groups and distributors to facilitate product approvals and on regulatory compliance issues;
• Applies standard procedures and leaned knowledge to develop regulatory solutions of moderate to low complexity within established guidelines. May collaborate with individuals at different levels in solving problems that are routine in nature. Interprets, executes and recommends modifications to operating policies where appropriate.

Minimum qualification requirements

Education

Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent education and experience sufficient to successfully perform the essential functions of the job may be considered.

Experience

Minimum 1 year in Regulatory Affairs, covering submission of the MD dossiers in Russia and/or EAEU.

Skills

• English level: pre-intermediate/intermediate or higher;