Regulatory Specialist

1 week 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 Job Title Regulatory Specialist (REMOTE or On-site)

Location(s) Oxford, UK - Oxford Immunotec

About Us

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. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our diverse team of 11,000+ colleagues from around the globe are vital to our success and the reason we're able to push boundaries in pursuit of better human health.

Find your future at Revvity

Job Overview: Regulatory Specialist

Company: Oxford Immunotec
Location: Abingdon, UK
Position Type: Fixed-Term, 9 months
Work Arrangement: 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. We offer regulated ELISPOT assays for T cell measurement, providing diagnostic solutions approved around the world.

Role Summary: 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 regions covered will Africa, LATAM, Middle Eastern, and India. The candidate must have IVD/Medical Device industry experience.

Role Description:

O verall 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

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