Oxford Immunotec, Inc.

Director, Regulatory Affairs, Blood Donor Screening

US-MA-Norwood
1 month ago
ID
2017-1775
# of Openings
1
Department
Quality & Regulatory

Overview

This position is responsible for the supervision, management and direction of the blood screening products and services Regulatory activities within Oxford Immunotec Ltd. The position will also have US regulatory management and supervision responsibilities for broader US related regulatory matters, including line management of US-based regulatory staff covering kit products and laboratory services.

Responsibilities

  • Regulatory Affairs (RA) responsibility for delivering Babesia blood screening BLA approvals. 
  • RA responsibility for Regulatory strategy to enable scale up of current business to meet blood screening demands in US. 
  • Establishing FDA requirements and submitting appropriate BLAs/BLA supplements to ensure business demands are met in a timely fashion.
  • Kit and Service responsibilities including RA oversight and planning regarding the move of kit manufacture of the Immunetics product from US to UK.
  • Leading FDA interaction on all blood screening matters.
  • Management and supervision of US-based Regulatory staff covering kit products and laboratory services.
  • Possibility for the role to expand to wider RA function with time.

Specific deliverables for the role are:

  • Lead the formulation of regulatory strategy (in both the US and EU) to ensure that eventual product approvals meet the company’s commercial needs with regards to blood screening business.
  • Lead all interactions with key regulatory bodies (CBER, CDRH, EU Competent Authorities) with respect to blood screening products and services.
  • Produce all the company’s US regulatory submissions and manage the submissions and review process with the FDA.
  • Oversee the company’s EU regulatory submissions (if applicable) to ensure that they are consistent with the overall regulatory strategy.
  • Work with the relevant groups to ensure manufacturing/product development/scale up activities meet risk management and design control requirements; regulatory processes are followed correctly and the design history files, manufacturing batch records, quality documentation, risk assessment etc., meet FDA’s standards.
  • Ensure ongoing Regulatory compliance post licensure.
  • Ensure UK QMS is in line with US FDA QSR and c-GMP specifically to enable approval of new manufacturing site for Babesia kit product.
  • Lead the process during FDA inspections of US and UK sites.
  • Manage US-based regulatory resources to ensure regulatory compliance with FDA and with CAP / CLIA requirements for kit products and laboratory services accordingly. 
  • Work, where relevant, with marketing to ensure that results from studies that are published are compliant with our technical data and meet FDA / regulatory requirements.
  • Adhere to the Company Quality Management System, including: ISO 13485:2016
  • Working to Oxford Immunotec’s Company Values at all times.

Qualifications

  • >10 years’ experience in the development and approval of life science products
  • >5 years’ experience holding senior management positions within Regulatory functions within med tech businesses
  • First-hand experience of managing Regulatory processes & departments
  • Experience of having successfully gained approval for PMA/510(k) or preferably BLA/supplements
  • Strong background in successful management of complex, major projects of strategic importance
  • Experience in manufacturing and quality functions an advantage
  • Experience of having launched products that changed clinical practice (i.e. not “me too” products) a distinct advantage
  • Experience of launching (gaining approval and/or clearance for) diagnostic products; ideally including both ‘wet’ science and automation/instrumentation a distinct advantage.

Emotional skills and abilities:

  • Advanced interpersonal skills which allow effective interaction and influence at all levels both internally and externally
  • Being able to see the big picture, whilst also having a commitment to excellence and attention to detail
  • Strong analytical skills
  • Effective negotiation capability
  • Highly intelligent and quick to learn
  • Must have ability to work in a medium-sized company environment
  • Proactive and willing to do things themselves
  • Courage and creativity to challenge the established way of doing thing

 

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