BioLegend, Inc.
Location
Oxford, Oxfordshire | United Kingdom
Job description
Overview
We are looking for a Senior Regulatory Specialist to join our team at Oxford Immunotec, part of the Revvity family to be responsible for the supervision and conduct of Global Regulatory activities.
This is a Hybrid role based in Abingdon, Oxford.
Responsibilities:
Overall responsibilities:
To assist the Head of Regulatory Affairs with the Company’s regulatory process leading to timely product approval for both new and existing products in line with Company goals.
To assist the Quality team in the management and continuous improvement of the Company’s Quality Management System as it relates to Regulatory activities in compliance with regulatory requirements.
To provide Global regulatory support to Sales and Commercial teams for ongoing requests for documents and information.
Specific deliverables for the role are:
To provide support to OI’s facilities to ensure that any regulatory needs are covered.
Assist with the conduct of Internal and External audits to agreed standards, with regard to the regulatory requirements
To take a central role in the preparation for and implementation of the requirements of the IVD Regulations
Assist with documentation and regular communication with regulatory authorities to ensure that we are in compliance with their requirements
Assist 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 (including other Revvity group companies) 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 and GMP)
To ensure that any annual administrative regulatory tasks are carried out in a timely manner
Deputising for the Head of Regulatory, wherever necessary
Operate effectively across departmental boundaries to resolve regulatory related issues in collaboration with peer group and other leaders
Working to Oxford Immunotec’s Company Values at all times.
Qualifications:
Technical skills and abilities
Educated to degree level with a minimum of 5 years relevant work experience
Good working knowledge of MS programs, the Internet and databases
Excellent knowledge of Quality Management systems, especially ISO 13485 and cGMP
Good working knowledge of MDSAP.
Strong regulatory experience within a medical device/diagnostics field with previous submissions experience in a range of territories including but not limited to US, EMEA, and APAC.
Strong written and oral communication skills
Good understanding of the scientific, biological and technical issues involved in developing diagnostic assays
Strong people management skills
Experience of the conduct of Internal and External Quality audits
Ability to operate at Supervisor level or above and demand respect of peer group
Emotional skills and abilities
Ability to think analytically, to solve problems and identify solutions
Ability to work with minimal supervision
Excellent attention to detail
Ability to continue to learn new skills and adapt to new ideas
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
Positive and enthusiastic
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