Team Leader, Regulatory Affairs

Building on 30 years of experience in transfusion diagnostics, AliveDx is committed to delivering solutions that reshape the way diagnostics is practiced.  AliveDx has two key product portfolios, Alba by Quotient™ and MosaiQ™ by Quotient. The Alba by Quotient™ product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ™ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. AliveDx operations are based in Eysins, Switzerland, Edinburgh, Scotland and Chicago, Illinois.

TEAM LEADER, REGULATORY AFFAIRS

The Regulatory Affairs Team Leader has a critical role responsible for regulatory registrations to enable the commercial maintenance and expansion of the ALBA product line.

The Regulatory Affairs Team Leader works closely with the Department Leader, Regulatory Affairs and with the wider Regulatory Affairs team to ensure compliance of Alba products with global regulatory requirements. The job holder is expected to act, where required, as a designate for the Department Leader, Regulatory Affairs and serve as backup PRRC.   The role will also be responsible for providing line management of junior regulatory staff who are direct reports as well as collaborating with other members of the Alba and wider AliveDx regulatory team as required.

JOB DESCRIPTION
The main responsibilities will include:

• Manage the business priorities and technical contributions of a team of regulatory administrative staff, regulatory officers and senior regulatory officers with accountability for the performance and results of the team
• Manage team resources and set priorities to ensure alignment of regulatory support with product development activities and regulatory reporting obligations for the Alba product portfolio 
• Mentor, train and develop junior regulatory affairs team members; develop and support individual training and development plans for line-managed team members to achieve required team performance.  Complete required performance management processes
• Collaborate with Regulatory Affairs Technical Leads to identify technical training needs for junior regulatory staff and ensure the continuous development of staff capabilities and preparation of high-quality regulatory assessments and submissions.
• Assist the Regulatory Affairs department leader in recruitment of junior staff
• Actively participate in multifunctional IVDR project team and lead the regulatory contribution to manage regulatory resourcing and ensure high quality submissions and timely certification to meet regulatory and business needs.  
• Actively participate in multifunctional project teams to provide guidance on regulatory requirements, provide supporting regulatory documentation, advise team members on data and information required for successful license applications, including reviewing of analytical study protocols/reports to ensure regulatory requirements are met.
• Prepare and compile regulatory documentation, coordinate and execute regulatory submission with:
  • FDA
  • European Notified Bodies
  • Health Canada
  • Any other territories as appropriate

•       Ensure maintenance of product regulatory documents and technical files to ensure ongoing          compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 CFRs, BLA, 510(k), CMDR – Part 1 requirements and other non-registered product requirements to support compliance.

QUALIFICATIONS, EXPERIENCE & BEHAVIOURS REQUIRED

• A relevant science degree and/or relevant work experience in a regulatory affairs environment.
• >6 years regulatory experience in medical device / IVD / biotech industry
• Experienced in meeting with, making presentations to, and negotiating with regulators.
• Ability to prepare coherent regulatory reports and filings.
• 3 years’ experience in team management, expertise in management of business contributions and development of junior staff
• High sense of responsibility and accountability to ensure compliance and to inspire team to do the same.

• ADDITIONAL INFORMATION
• Competitive salary on offer.
• AliveDx offer a range of core and flexible benefits ranging from private medical cover, life assurance, cycle to work, technology, and restaurant discounts.