BOGOTÁ D.C, 110111, CO
Job details
Work flexibility: Hybrid
Req ID: R540442
Employee type: Full Time
Job category: RAQA
Travel: 0%
Relocation: No
Related content
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
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.
- In-depth knowledge of regulatory requirements for medical devices, including the Medical Device Directive, EU Medical Device Regulations, Quality Systems, and Post Market Surveillance.
- Experience in facilitating meetings with regulatory agencies, conducting internal and external audits, and preparing necessary briefings and documentation.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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