Senior Regulatory Affairs Specialist

1 week ago

Dublin, Dublin City, Ireland beBeeSpecialist Full time €80,000 - €100,000

Job Title

">Senior Regulatory Affairs Specialist - Medical Devices

 

Description:

  • We are seeking an experienced Senior Regulatory Affairs Specialist to join our team in the development and implementation of regulatory strategies for medical devices. The ideal candidate will have a strong background in medical device regulation, including knowledge of US and EU regulations, as well as experience with post-market surveillance and adverse event reporting.
  • The successful candidate will be responsible for developing and implementing regulatory strategies for new and existing products, working closely with cross-functional teams to ensure compliance with regulatory requirements.
  • This role requires excellent communication and project management skills, with the ability to work effectively in a fast-paced environment and prioritize multiple tasks and deadlines.
  • We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

Requirements:

  • Bachelor's degree in science, math, engineering, or related discipline required; Master's degree preferred
  • At least 5 years of experience in medical device regulation, including post-market surveillance and adverse event reporting
  • Strong knowledge of US and EU regulations, including 21 CFR 803/806/820 and ISO 13485
  • Excellent communication and project management skills
  • Able to work effectively in a fast-paced environment and prioritize multiple tasks and deadlines

Preferred Qualifications:

  • Regulatory Affairs Certifications (RAC)
  • Experience with administration and safety systems
  • International regulatory competency

Travel Requirements: Up to 13 business days per year

Benefits:

  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • Flexible work environment

Additional Requirements:

  • Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
  • Ability to comprehend principles of math, science, engineering, and medical device use.
  • Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
  • Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
  • Ability to review, collate, describe, and summarize scientific and technical data.
  • Ability to organize complex information and combine pieces of information to form general rules or conclusions.
  • Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
  • Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
  • Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
  • Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.

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