Senior Regulatory Lead

Company Description
We are a leader in liquid biopsy. Every day we transform the lives of cancer patients and their families through the power of liquid biopsy. Our tests unlock essential genomic information from a simple blood test and allow clinicians to make more informed treatment decisions for their patients.

We are dynamic and innovative, focused on the development of new ground-breaking technologies in a fast-paced and international setting. Our exceptional team of talented and driven individuals work together to combine their energy and expertise in world-class research, product development and commercialization to bring new tests to the patients that need them.

If making a difference is in your DNA and you are ready to join the liquid biopsy revolution, then you could be just the person we are looking for to join our team based in Cambridge, UK!

Position
Role Overview:

The Senior Regulatory Lead represents the regulatory affairs function on assigned cross-functional project teams and leads activities associated with regulatory submissions and registration of in vitro companion diagnostic medical devices. The position liaises with key internal and external stakeholders to develop sound regulatory strategies, to ensure regulatory compliance in product development and to draft, review and maintain high quality regulatory compliant documentation for IVDs.

Key Responsibilities:

Work in a cross-disciplinary team to define global regulatory/validation strategies for the development and delivery of tests for use in clinical development programs and for companion diagnostics
Lead interactions with regulatory agencies including the US FDA and EU Notified Bodies
Represent Inivata before regulators, external partners and internal customers on regulatory and technical matters, as needed
Lead interactions with regulatory agencies including the US FDA and EU Notified Bodies
Write, prepare, edit, review and submit FDA submissions including, but not limited to:
Q-submissions
IDE/IND Applications
Pre-market applications (NDAs, PMAs, BLAs)
Post-market reports
Write, prepare, edit, review and submit EU technical files
Provide support for marketed products, e.g., review engineering changes, labeling, promotional material, and product changes for compliance
Support change control activities that require regulatory agency approval per US regulatory requirements
Actively maintain current knowledge of applicable regulatory requirements and standards and scientific/technical issues in the discipline as relevant to assigned projects
Review and edit technical documents to be included in regulatory dossiers, which may include software validation protocols and reports and/or other software development documentation
Participate in design control activities and audits
Create and maintain regulatory procedures
Other duties as assigned
HIPAA/GDPR Compliance: Position will

Agree to abide by Employment and Confidentiality Agreements and End User Policies
Commit to stay up to date on training requirements for HIPAA/GDPR
Understand the importance of the proper handling and disposal of ePHI and agrees to follow HIPAA/GDPR Regulations
Abide by the requirements for the proper disposal of equipment containing ePHI
Agree to report breaches and the improper handling of ePHI to the Company’s Privacy and Security Officers
Produce and adhere to proper validation documentation

Requirements
Technical Requirement:

Bachelor’s degree in a scientific discipline required, Master’s degree or higher preferred
Regulatory affairs experience within the LDT and IVD field required, with RAC preferred
Experience with Companion Diagnostics
Knowledge and demonstrated experience with USA and EU regulatory agencies
Experience with FDA and EU Notified Bodies
Additional international/global regulatory experience a benefit
Skill requirement:

Track record of drafting, writing and submitting regulatory documents and ensuring compliance related to quality, manufacturing standards, clinical trials, submission data, etc.
Demonstrated experience in FDA audit experience (GMP/QSR, BIMO) with successful outcomes
In-depth knowledge of relevant regulatory guidelines and requirements, with a focus on the US and EU CE Mark with a demonstrated record of success in gaining regulatory approval
Ability and willingness to work in a lean, start-up like environment

Other information
Our Values guide all our activities:

We are BOLD with the delivery of cutting edge science.

We are PASSIONATE we love what we do, our purpose and our impact on patients is clear

We are CARING we care for our patients, our partners, customers and colleagues

Inivata Limited is based in Cambridge, UK.

No agencies please.

www.inivata.com

We look forward to reviewing your application!

Application Closing Date: 
15 December