Catalyst Recruitment - People + Progress

Regulatory Affairs Specialist

£35,000 to £45,000 / Newcastle upon Tyne / Jun 4, 2019

Our client is a truly pioneering, VC-backed Health Technology company, now entering a new and tremendously exciting phase of its development, having very recently secured significant Series A funding to accelerate its growth to a long-term sales target of £1.5bn, marketing a suite of early diagnostic tests via insurers and an ecosystem of partners. 
It’s an amazing time to join a company with incredible potential to improve the lives of many millions of people globally, playing an important role in its development as a Regulatory Affairs Specialist.

As a member of a highly experienced, lean and visionary team aiming to transform lives by diagnosing disease early, this role is responsible for ensuring that the company obtains regulatory approval for its products in line with the business plan and ensuring on-going compliance with regulatory requirements. 
Reporting to the CTO, your responsibilities as Regulatory Affairs Specialist will include: 
  • Compile and maintain regulatory documentation, databases and systems. Maintain knowledge base of existing and emerging regulations, standards, or guidance documents
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards
  • Prepare or maintain technical files as necessary to obtain and sustain product approval
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires
  • Develop or conduct employee regulatory training
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
  • Review product promotional materials, labelling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies
  • Advise project teams on subjects such as premarket regulatory requirements, export and labelling requirements, or clinical study compliance issues
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance
Regulatory submissions / approvals:
  • Coordinate efforts associated with the preparation of regulatory documents or submissions
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device or labelling changes.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies
  • Participate in internal or external audits
  • Recommend changes to company procedures in response to changes in regulations or standards
  • Review clinical protocols to ensure collection of data needed for regulatory submissions
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures
Additionally, this position may require travel. Travel may be UK or international. Travel may take place on weekends or outside of normal business hours.

As Regulatory Affairs Specialist you’ll be/need:
  • Bachelor's degree or equivalent level qualification in a relevant life science subject
  • Relevant experience in regulatory affairs in life sciences, diagnostics or a related health area
  • A desire to make a positive impact on the world
  • Ability to think analytically and strategically
  • A keen eye for detail
  • Demonstrable passion for achieving regulatory approval of medical devices
  • Ability to effectively communicate complex ideas, both orally and in writing
  • Good understanding of the US (FDA) and European (CE) regulatory systems
  • Good understanding of the subject of medical devices, in particular, invitro diagnostics (IVDs)
  • Experience, but not necessarily the lead, in achieving medical device regulatory approvals
  • Good organizational, IT and administrative skills
  • Experience of use of MS Office software, particularly Word, Excel, PowerPoint and database software
Additionally desirable:
  • A recognized post-graduate qualification in regulatory affairs or similar specialism
  • Extensive experience and a prior portfolio of delivered regulatory approvals
  • Prior experience of building contacts with regulators (ideally FDA) and regulatory consultants relevant to life sciences and diagnostics
  • Detailed understanding of the regulatory systems across the US (FDA) and Europe (CE)
  • Relevant experience leading and achieving regulatory approvals for medical devices
  • Knowledge and understanding of 2D electrophoresis
  • Some knowledge or understanding of regulatory systems in other jurisdictions
  • A clean UK driving licence

Salary: Competitive depending on skills, experience and regulatory approval track record. Please state your requirement on application
Please note: High levels of interest mean we will only contact you if your application is shortlisted and this will happen within five working days. You must also be eligible to work in the UK.

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