Regulatory Affairs Specialist

at  DemantPoland

71-612 Szczecin, województwo zachodniopomorskie, Poland -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate30 Apr, 2025Not Specified01 Feb, 2025N/AGood communication skillsNoNo
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Description:

We are on an exciting growth path and right now we are enhancing our capabilities in our Regulatory Compliance Team. If you are looking for a job in a top professional global organization, this is the perfect place to do so!
As our new Regulatory Affairs specialist your main task will be to ensure that product registrations are running smoothly and are properly maintained. You will also play an active role in guiding our many brands in relation to how they must deal with regulatory requirements and constant changes in a complex regulatory landscape.

Responsibilities:

  • Maintaining technical documentation for electronic and electrical devices
  • monitoring global regulatory changes, assessing their impact and communicate regulatory changes to the organization;
  • responsible for new products certification
  • responsible for existing products renewal process
  • collecting required documents and preparing regulatory documentation packages
  • cooperating with external stakeholders in relation to certification
  • developing and maintaining processes and procedures
  • work in cross-functional projects
  • Supporting maintenance of the quality management system with applicable industry standards and regulations as necessary
  • ensuring new standards and recertification are handled and new standards implemented in our knowledge base
  • Further, you can look forward to being the primary interface to external approval authorities as well as internal Sales and Product Management teams.


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

71-612 Szczecin, Poland