Senior Regulatory Affairs Specialist

hace 1 mes


Bogotá, Colombia Stryker Group A tiempo completo

What you will do

  • Execute regulatory affairs (RA) activities in accordance with defined procedures and processes.

  • Collect, organize, and maintain files on local, regional, and global RAQA intelligence.

  • Identify the need for new regulatory procedures and SOPs, participating in their development and implementation.

  • Suggest and support continuous improvement initiatives across RA processes.

  • Achieve established targets, KPIs, and objectives for RA activities.

  • Provide support to LATAM/country RA teams and assist local RAQA leaders with data collection for performance, risks, and issues reporting.

  • Act as a subject matter expert for the local business, supporting the development and deployment of systems and procedures.

  • Facilitate the integration of new acquisitions, ensuring RAQA system integration, and support talent recruitment, onboarding, and development at the local office.

What you will need
  • Hold a BSc degree in a relevant field; an advanced degree is preferred, and RAC certification is also advantageous.

  • 4+ years of experience in regulatory affairs.

  • Conversational level in English.

  • Demonstrated skills in project and time management, with proficiency in writing, coordinating, and executing complex RA tasks.

  • In-depth knowledge of regulatory requirements for medical devices, including the Medical Device Directive, EU Medical Device Regulations, Quality Systems, and Post Market Surveillance.

  • Proven ability to influence across the organization and lead technical and scientific RA activities independently.

  • Experience in facilitating meetings with regulatory agencies, conducting internal and external audits, and preparing necessary briefings and documentation.

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