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Regulatory Affairs Specialist

Brite Recruitment Ltd
Job LocationBirmingham
EducationNot Mentioned
Salary£35,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract , full-time Work from home18 Months FTC

Job Description

REGULATORY AFFAIRS SPECIALISTBIRMINGHAM/HYBRID£35,00018month FTCSUMMARYOur global manufacturing client is looking for a Regulatory Affairs Specialist, to play a pivotal role in ensuring the company’s compliance with regulatory standards for medical devices. You will contribute to regulatory submissions, managing CE-making/CA-making activities, and overseeing technical documentation compliance.RESPONSIBILITIESAs a Regulatory Affairs Specialist, you will be,

  • Overseeing regulatory submission and CE-marking/CA-marking activities
  • Creating and updating technical documents for certification/re-certification
  • Reviewing and approving technical documentation reports for compliance
  • Leading and managing specific regulatory activities such as biocompatibility testing and clinical evaluation plans
  • Collaborating with cross-functional teams and mentoring junior team members in technical writing and compliance approaches
  • Participating in risk management activities for product ranges
REQUIREMENTSTo be considered for the Regulatory Affairs Specialist role,you must have,
  • A degree in Sciences, Engineering, or a similar subject is desirable
  • Strong experience in a medical device or pharmaceutical role
  • An excellent understanding of regulatory operation and the MDR
  • Experience in producing technical documentation
  • A working knowledge of global medical device regulations and international standards
  • The ability to multi-task, prioritise, and effectively meet deadlines
  • Strong IT skills, especially in Word, Excel, and PowerPoint
  • Quality focus, communication, and influencing skills
  • Excellent interpersonal and communication skills
NEXT STEPSIf you’re interested in becoming a Regulatory Affairs Specialist apply today with your current CV. Our team will review your application to see if it’s a match and get in touch to learn more about you. If you arent contacted within 7 days,please assume your application was not selected.Why wait Don’t miss out!

Keyskills :
Regulatory Affairs

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