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Regulatory Specialist

TEC PARTNERS LIMITED
Job LocationNorfolk
EducationNot Mentioned
Salary45,000 - 55,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

This role is for a market leading company designing, developing, and manufacturing drug delivery devices across the globe. They are leading the way in drug delivery device innovation, driven by customer and patent demand, offering the potential to createnew treatments and opportunities worldwide.Regulatory Specialist:As a key member of the Regulatory team, you will provide specialist advice and information throughout the company to understand, plan and support the design, development, and commercialisation of products with a focus on New Product Introduction (NPI) programmes.You will work closely with internal stakeholders, customers and suppliers/other companies to understand, plan and execute the design and development stages and develop regulatory strategies for NPI ensuring relevant standards and guidances are identifiedand incorporated as required ensuring compliance at all times for regulatory submissions and licences.Regulatory Specialist Role:

  • Identify, define, and deliver of Regulatory deliverables for NPI programmes and marketed products as required to ensure product quality and compliance, within agreed cost and timelines.
  • Develop and maintain up to date relevant legislative, compliance and regulatory knowledge applicable to the company. Ensure that Pharmaceutical, Medical Device and Drug-Device Combination Product Regulatory Affairs policies, procedures and processes arerevised as required, to ensure compliance and followed at all times.
  • Provide direction, advice, training and guidance to employees regarding compliance and regulatory issues, including the review and implementation of QMS transactions (e.g. change controls).
  • Proactively pursue continuous improvement opportunities within the Regulatory processes.
  • Maintain regulatory licences, site registrations and listings to ensure they are current.
  • Manage and maintain records of all required Regulatory compliance statements and certificates within the agreed timeframe to ensure that customer requests are met.
Regulatory Specialist Requirements:
  • Proficiency in quality systems (ISO 13485), associated documentation
  • Proficient in medical device industry and medical device regulations
  • Risk management ISO 14971 experience
  • Bachelors degree in a related field
  • Minimum 5 years experience working in Quality and Regulatory roles within Medical devices
  • Be passionate about technology, healthcare and entrepreneurship
  • Be driven, motivated and organised
  • Be a team player with demonstrable leadership potential
  • Be a quick learner willing to throw themselves into new challenges
This is a fantastic opportunity to join a diverse and inclusive business where authenticity is promoted alongside the growth and development where you can further you career in a fast paced environment with likeminded individuals. As part of the opportunity,you will be granted development opportunities, competitive salary options along with an additional benefits package.If this opportunity is of interest, please apply with an up to date CV.

Keyskills :
DMFMedical DevicesMHRANPIREgulatory AffairsExternal Ausit

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