Director- head of regulatory affairs and quality assurance - - united kingdom, oxford, oxfordshire

rbw are exclusively partnered with an early-phase medical device company, in their search for a new head of regulatory. they have an innovative combination platform with proven capability to enhance drug delivery, primarily within oncology and with work ongoing for a range of indications.

they are now seeking a director-level professional to join them, predominantly as head of regulatory affairs, responsible for managing the regulatory activities with a reporting line directly to the coo. the role also has oversight of the company s quality assurance function through line management of the qa manager and senior quality specialist.

at clinical stage, the company is currently engaged in a first-in-human trial and is working with collaborators to initiate further trials over the next year, so it's a really exciting role as you will be instrumental in researching and selecting territories for future growth.

core responsibilities

regulatory affairs

working with members of the senior management team to define and implement the regulatory strategy for the uk, usa, eu and other territories

working closely with the chief medical officer to provide regulatory input into the clinical strategy

keeping up to date with regulatory developments in the key territories and updating the regulatory strategy accordingly.

leading discussions and communication with notified bodies, competent authorities, and the fda.

engaging with specialist consultants as required to address specific regional challenges.

supervising and coordinating the compilation of dossiers and documentation required for regulatory submissions.

supporting the medical function in the preparation of regulatory submissions to ethics committees and competent authorities.

supporting the technical teams in the planning and review of regulatory documentation.

assistance in writing key reports and undertaking gap analysis to identify missing documents.

quality assurance

line management of the raqa manager and senior quality specialist to maintain ongoing iso 13485 compliance.

promote awareness in the company of applicable regulatory requirements.

support the preparation and compilation of dhf documentation.

ensure periodic management review takes place, updating on the effectiveness of the qms and any need for improvement.

ensure that quality objectives appropriate to product safety and to the company s regulatory strategy are set and monitored by the senior management team.

required qualification and experience

a degree in a scientific related discipline

minimum of 5 years experience within regulatory affairs for medical device development (class ii and above), and experience of class iii sterile devices.

experience working within an iso 13485-compliant environment

proven experience interpreting and disseminating regulatory requirements for complex and/or novel medical devices

has previously managed the submission of clinical trial application dossier to fda or a competent authority such as mhra.

an understanding of eu and/or us regulatory requirements relating to combination products and medicinal products is desirable

experience within oncology indications would be favorable but is not essential

experience of team line management is essential.

personal capabilities

the ability to assimilate a high volume of information from different stakeholders and distill this information into cogent tactical summaries and proposals.

the ability to communicate efficiently and effectively both verbally and in written form with cross-functional stakeholders such as technical, clinical, and commercial.

a proven ability to plan, coordinate and manage complex multiple multi-disciplinary projects simultaneously.

the ability and interest in gaining a comprehensive understanding of multi-disciplinary technologies not necessarily within one s own area of expertise

important information

the company operates a flexible hybrid working model, with time split between the oxford office and home-working. teams are responsible for selecting their own working patterns, with only essential meetings required on site.

the salary on offer is negotiable dependent on experience, around gbp90-100,000 pa, and you will also receive share options with no vesting time limit.

there is a really generous 12% pension, as well as axa healthcare.

please apply today, or feel free to contact katie dunbar at rbw consulting for more information on 952176.

More jobs