Senior Regulatory Affairs Specialist

2 weeks ago

Oxford Oxfordshire, United Kingdom GBXB Oxford Immunotec Limited Full time

Regulatory Specialist (REMOTE or On-site) page is loaded Regulatory Specialist (REMOTE or On-site)
Apply locations Oxford, UK - Oxford Immunotec time type Full time posted on Posted 3 Days Ago job requisition id JR-038611 Job Title
Regulatory Specialist (REMOTE or On-site)

Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. Regulatory Specialist
Position Type: Fixed-Term, 9 months
On-site OR REMOTE
Company Overview: Oxford Immunotec, a Revvity company is a leading global diagnostics company dedicated to bringing energy and innovation to the field of diagnostic testing. Oxford Immunotec is seeking a Regulatory Specialist to join our team for a fixed term of 9 months and will be Global Regulatory activities within Oxford Immunotec (Revvity). The Regulatory Specialist will work with the company's regulatory process leading to timely product approval for both new and existing products in line with company goals. The candidate must have IVD/Medical Device industry experience.
To assist the Regulatory team with the Company’s regulatory process leading to timely product approval for both new and existing products in line with Company goals.
To provide Global regulatory support to Sales and Commercial teams for ongoing requests for documents and information
To work with the Quality team to ensure that verification and validation activities as well as risk management are carried out to support Global regulatory requirements
To provide support to OI’s facilities to ensure that any regulatory needs are covered.
To take a supporting role in the preparation for and implementation of the requirements of global IVD Regulations.
To take a central role with documentation and to support regular communication with regulatory authorities to ensure that we are in compliance with their requirements
To take a supporting role with the provision of regulatory affairs input to research and development programs in order to ensure that these programs deliver products that are capable of early product approval by regulators
Communication with distributors to ensure good relationship management from a regulatory perspective when required
To assist with the maintenance of OI certification to international quality standards to ensure regulatory compliance (ISO 13485, ISO 17025 and GMP)
To provide review of sales and marketing documents from the regulatory perspective
To work with and support the Regulatory Officer to ensure that any annual administrative regulatory tasks are carried out in a timely manner.
Operate effectively across departmental boundaries to resolve regulatory related issues in collaboration with peer group and other stakeholders
Educated to degree level or higher or with a minimum of 5 years relevant experience within IVD/MD Quality Assurance, Regulatory Affairs, or similar environment
Good working knowledge of MS programs, the Internet and databases
Excellent knowledge of Quality Management systems, especially ISO 13485 and cGMP
Good understanding of the submissions process, ideally in a medical device/diagnostics field.
Understanding of the scientific, biological and technical issues involved in developing diagnostic assays
Experience of the conduct of Internal and External Quality audits
Excellent interpersonal skills employed to communicate with individuals on all levels and from different areas of the business
Team working profile with a co-operative and proactive attitude to other staff, collaborators and senior managers
LI-EMEA
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