Regulatory Specialist
1 month ago
This position is offered as a fixed term contract (FTC) of circa 9 months and is responsible for Global Regulatory activities within Oxford Immunotec (Revvity)
Role Description:
Overall responsibilities:
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
Specific deliverables for the role are:
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
Working to Company Values at all times.
Role Requirements
Technical skills and abilities
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.
Strong written and oral communication skills
Understanding of the scientific, biological and technical issues involved in developing diagnostic assays
Experience of the conduct of Internal and External Quality audits
Emotional skills and abilities
Ability to think analytically, to solve problems and identify solutions
Ability to work with minimal supervision•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
Ability to manage people effectively
Team working profile with a co-operative and proactive attitude to other staff, collaborators and senior managers
Bright, energetic and enthusiastic
What we Offer:
Purposeful & inclusive work environment
Dynamic culture in which customers are at the forefront
Being part of a highly qualified team that is committed to excellence
Access to cutting-edge expertise through which you can make positive impact in the world around us
#LI-EMEA
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