The company
Medella Life is working with a market leading medical device company who are specialise in redefining respiratory care. They are in the process of expanding their leadership team in the US and are seeking a Director Quality and Regulatory Affairs to join them!
The role
You will work directly with the Operations and Design teams to support the rapidly growing manufacturing of the company’s leading product. If you enjoy being part of a collaborative team, building relationships and making a difference, then we want to hear from you! The Senior Regulatory Affairs (RA) Specialist assesses product changes for reportability to appropriate regulatory agencies. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
Responsibilities:
Prepare and maintain regulatory submissions, maintain 510k product registrations.
Approve design/manufacturing changes. Analyze product changes for impact to current regulatory filings
Maintain current standards list. Identify and lead projects to comply with latest standards (FDA expectation)
Regulatory Intelligence: Monitor regulatory environment (FDA), Provide regulatory environment update in Management Reviews
Primary point of contact for FDA interaction (questions/responses). Participate in FDA inspection as needed.
Recall administration
Participate in/lead internal audits
Stay current on international regulatory requirements and lead appropriately regulatory approvals. Lead CE mark requirement definition/implementation
Support maintaining a cGMP compliant Quality Management System to ensure the Quality System is established and maintained in accordance with FDA 21 CFR 820, cGMP, (MDD 93/42/EEC, MDR 2017/745,) and ISO 13485 regulatory requirements.
Develop relevant regulatory procedures and work instructions as necessary.
Lead audit readiness initiative. Investigate and document issues relating to the product, process, or Quality System relevant to the regulatory compliance.
Requirement
Bachelor’s degree in engineering or life science discipline, or equivalent experience
Minimum 7 years of RA experience in the medical device industry
Strong understanding of ISO 13485 and FDA 21 CFR Part 820 requirements
Strong understanding of statistical techniques
Regulatory Affairs Certification (RAC) highly preferred
Excellent communication and documentation skills
Strong organization and attention to detail skills
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