My client is a digital health company who specialise in chronic diseases. They have FDA cleared medical devices as well as secure access to clinical data to provide monitoring. It is an exciting time for the company as they are looking to grow out their regulatory department! They are seeking a Regulatory Affairs Consultant to join their dynamic team! This is a remote position
The role
The Regulatory Affairs Consultant helps create, develop and maintain materials needed for regulatory compliance. Assists with company compliance activities, new product submissions, listings, and registration of medical devices. Works independently as necessary.
Responsibilities
- Understands regulations, follows complex directions, and investigates when clarification is needed.
- Initiates International product registration, including renewals or changes and certificates for foreign governments
- Manages correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, Medimark
- Prepares, organizes, and coordinates data for submission to the FDA or regulatory agencies (e.g. 510(k), MDD Technical Files, etc.)
- Participates in the preparation and execution of ISO and FDA audits
- Assures regulatory compliance and content accuracy of Technical Files and 510(k) files
- Completes the duties described in the Quality Manual
- Converts and/or approves ECRs/ECOs requiring regulatory review
- Assists in package insert (instructions for use) development, organization and application
- Assists in determination of appropriate safety, regulatory, evaluation and testing requirements for new and approved products
- Product development design review team and risk team contributor, providing regulatory/compliance perspective and expertise, to assure products are in compliance with relevant US and foreign standards, codes and regulations
- Reports standards changes and summarizes impact on the company’s products
- Involvement in new country/market registration as required
- Assists in labeling (e.g. package inserts/IFUs(instructions for use), marketing materials, package labels, etc.) development, organization, application and/or review
- Assists in development of company regulatory strategies and determine priorities with Sales & Marketing, Engineering and Quality
- Reports standards changes, determines impact and takes appropriate action
- Provides regulatory training to lower level regulatory personnel
- Assistance with compiling documentation in support of 510k (HW and SW)
- Creating an updated process for management of our EU Tech File and DHF for SaMD devices, utilizing our eQMS
Qualifications
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything
- Bachelor of Science in Biology, Chemistry or related field required
- Thorough working knowledge of applicable FDA, CMDCAS, ISO, and MDD requirements and consensus standards
- 3 - 5 years of regulatory experience or 5+ years of experience in the medical device or equivalent industry (quality or orthopedic engineering)
- 3-5 years’ experience of US and EU experience
- Experience in SaMD
- Ability to support and execute activities related to product development teams and projects
- Ability to work well with others and manage projects
- Excellent written and verbal communication skills
- Ability to read and speak English sufficiently to read, understand and complete all documentation.
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything