- Working closely alongside the Regulatory Affairs Manager, you will support in the building and maintenance of technical files and submissions for global regulators.
- Using your regulatory knowledge, you will support regulatory strategies toward successful submission to regulatory agencies.
- A key aspect of the role will be to analyse routes to market (e.g., 510[k], PMA and IVDR) and provide relevant information to the senior regulatory team through use of regulatory intelligence databases and review of guidance documentation (e.g., FDA, MDCG).
- You will support the larger Regulatory Affairs team in initiatives and be responsible for the development and maintenance of regulatory processes to ensure that pre and post launch regulatory obligations are met (e.g., development and maintenance of procedures, monitoring of regulatory licences etc).
- You will maintain accurate records in relation to regulatory procedures, processes and filings.
- You will work collaboratively across departments and foster supportive and effective project teams.
- You will support the developing and training of project teams in new areas of regulatory affairs so that they have an awareness and understanding of regulatory requirements.
- Work alongside project development teams to ensure that design and development processes are in compliance with relevant global regulations and standards to help assure that outputs of design and development support future regulatory filings.
- Degree level in a science subject (e.g., molecular biology, biomedical sciences) along with two or more years of working in a regulatory affairs department in the diagnostics or medical devices industry
- A strong working knowledge of FDA: 21 CFR EU: IVDR (or MDR) + MDCG and ISO 13485 / ISO 14971
- Strong communicator with ability to break down complex information to share with multi-functional teams coupled with excellent writing skills.
- As the role will work across different departments strong team working skills are required in addition to analytical and problem solving skills.
- The role will require the successful candidate to make decision and act, with understanding of when to escalate
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Regulatory Affairs Specialist - Oxford, United Kingdom - Oxford Nanopore Technologies
Description
About Us
Oxford Nanopore Technologies is headquartered at the Oxford Science Park outside Oxford, UK, with satellite offices and commercial presence in many global locations across the US, APAC and Europe. Oxford Nanopore employs from multiple subject areas including nanopore science, molecular biology and applications, informatics, engineering, electronics, manufacturing and commercialisation. The management team, led by CEO Dr Gordon Sanghera, has a track record of delivering disruptive technologies to the market.
Oxford Nanopore's sequencing platform is the only technology that offers real-time analysis (for rapid insights), in fully scalable formats from pocket to population scale, that can analyse native DNA or RNA and sequence any length of fragment to achieve short to ultra-long read lengths.
Our goal is to enable the analysis of any living thing, by anyone, anywhere. We offer real-time nanopore-based DNA/RNA sequencing technology: accessible, easy to use and fully scalable for any requirement.
Summary
Oxford Nanopore Diagnostics is seeking a new regulatory affairs specialist to join the regulatory team to help support the continued expansion of its ISO 13485 Diagnostics product pipeline. Reporting to the Regulatory Affairs Manager, you will work closely with product development teams in ensuring that design and development processes are in compliance with relevant global regulations and standards.
The role will provide regulatory support for new and existing projects, ensuring regulatory compliance, and will maintain effective working relationships with key stakeholders (both technical and non-technical teams) within both OND and ONT (Oxford Nanopore Technologies, the parent company).
Key Responsibilities:
Specific duties include but are not limited to:
Qualifications/Experience/Skills:
We offer outstanding benefits to include an attractive bonus, generous pension contributions, private healthcare and an excellent starting salary. Based within beautiful, landscaped surroundings with tree-lined walks, water features and a lake, all of which make for a wonderful working environment.
If you are looking to utilise your skills to really make a difference to humankind, then consider joining our team and apply today
