It’s about time… to combat antimicrobial resistance.
Director of Regulatory & Quality
- Are you looking for a rewarding career?
- Would you enjoy working as part of a team helping to research and deliver advances in medicine?
- Are you hard working, flexible and happy to “go the extra mile” for the benefit of the team?
If the answer is ‘YES’ , we may have just the role for you!
Reports to: COO
ODx Innovations Ltd. is a UK based life sciences technology company working with global partners to develop cutting-edge medical devices. We are developing technologies to transform the performance of antibiotic sensitivity testing laboratory and point-of-care products. We are rapidly scaling up and we need a talented Director of Regulatory & Quality to support our growth.
It is our mission to bring cost-effective, accurate and speedy technology solutions to address the growing problem of bacterial resistance to antibiotics. Developing technologies which will dramatically increase the speed of results for patients and will enable faster and more accurate prescribing of the most appropriate antibiotics.
A newly created position providing an exciting opportunity to shape your role and lead and develop the regulatory affairs / quality team. This position is based in Inverness although flexible home working is also possible due to the nature of the work. Some international travel will be involved.
The Quality Manager directly reports to the Director of Regulatory & Quality and has responsibility for design, implementation and maintenance of the ISO 13485 accredited QMS.
The role of the Director of Regulatory & Quality within ODx is to ensure that the systems and processes within ODx are compliant and that the products developed successfully meet and exceed all applicable regulatory requirements, laws, legislation and international guidance for the quality, safety and efficacy of the product from development throughout the product lifecycle for the chosen markets they the will be sold to. The Director of Regulatory and Quality will be responsible for providing clear Regulatory guidance throughout the product lifecycle.
As a key member of the management team, this position will demonstrate a high level of regulatory expertise and leadership in order to ensure ODx continuously demonstrates outstanding levels of compliance and quality excellence. The position is responsible for establishing regulatory policy for the company and represent the company at external meetings and at Industry Associations.
The position holds direct responsibility for achieving all relevant ODx process, product compliance certification and accreditation from the relevant Regulatory Bodies within the required ODx timelines.
Key Roles and Responsibilities:
- Ensuring that Regulatory Affairs projects are delivered to exceptional standards.
- Providing regulatory expertise to projects being performed by ODx.
- Liaising with regulatory authorities for marketing authorisation.
- Preparing submissions of licence variations and renewals to strict deadlines.
- Writing clear, accessible product labels and patient information leaflets.
- Specifying storage, labelling and packaging requirement.
- Planning and developing product trials and interpreting trial data.
- Advising scientists and manufacturers on regulatory requirements.
- Providing strategic advice throughout the development of a new product.
- Accountable for the performance of the regulatory affairs function within budget.
- Line management and recruitment of quality and regulatory staff.
- Effective implementation of agreed departmental strategies.
- Presenting to colleagues, partners, regulatory bodies, and other professional audiences.
- Reviewing company practices and providing advice on changes to systems.
- Educated to at least a relevant science degree level, preferably with a higher degree in a pharmaceutical discipline.
- At least seven years of experience in pharmaceutical Regulatory Affairs.
- Several years of experience and broad knowledge in the field of Point of Care (PoC) medical devices
- An in-depth understanding of current global and regional trends in Regulatory Affairs.
- Excellent written and verbal communication skills, with a focus on client-facing interactions.
- Proficient leadership qualities.
- Capability to professionally represent the department and the company both externally and internally
- Experience in defining, developing and implementing processes.
- Capability to analyse problems and to be a solution provider.
- Autonomous, concentrated and high-quality work.
- Team player who thrives in a high paced environment.
- BS EN ISO 13485:2016 experience.
- Management experience with cross-functional relationships.
All internal teams.
Regulatory bodies (e.g. FDA, MHRA, etc), accreditation providers (e.g. ISO), partners, contractors, prospective customers and R&D partners, KOL, company professional advisors, shareholders.APPLY HERE