Job Description

We are seeking a Regulatory Affairs Consultant to work with our client on part-time basis to help with the below core responsiblities. A great opportunity to extra part-time work or as an opportunity to convert to a permanent position.

Responsibilities

• Technical Documentation: Write, analyze, and edit technical documents to support country-specific Regulatory submissions.
• Regulatory Submissions: Compile submissions in a format consistent with applicable guidance documents, including submissions in the USA, Canada, Europe, and other countries.
• Regulatory Files: Create, maintain and update Regulatory authorizations, such as 510(k)s, Canadian medical device licenses, and CE dossiers.
• Compliance: Ensure appropriate maintenance of registrations, including renewals, device listings, site registrations, supplements for changes, and annual reports.
• Communication: Work with other departments and communicate submission requirements when documents are needed for Regulatory submission.
• Regulatory Climate: Stay abreast of Regulatory procedures and changes in the Regulatory climate.
• Support change control process.
• Perform labeling Regulatory reviews/approvals as required.
• Develop and maintain Regulatory procedures.
• Support internal and external Regulatory agency audits, providing Regulatory input to minimize potential findings of non-compliance.

Qualifications

• Bachelor’s degree in a scientific discipline (e.g., Life Sciences, Biology, Chemistry, Engineering, Regulatory Science).
• Certificates, Licenses, Registrations.
• 3+ years’ Medical Device Regulatory experience.
• Experience with FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), and other international Regulatory requirements (e.g. EU Medical Device Regulations).
• Experience with FDA submissions (510(k), PMA, etc.), CE marking submissions, and international product registrations.
• Coordinate with applicable stakeholders, to support Regulatory submissions.
• Able to work independently as well as part of a team
• Adaptable and flexible
• Attention to detail and ability to manage multiple projects simultaneously.

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