Regulatory Affairs and Quality Assurance Expert
hace 1 semana
At Werfenlife SA, we are seeking a highly skilled Regulatory Affairs and Quality Assurance Expert to support the implementation and execution of regulatory and quality plans. As part of our team, you will be responsible for ensuring compliance with RAQA record management processes, leading and managing non-conformities, and preparing regulatory submissions.
Key Responsibilities
- Support RAQA management with a business focus, ensuring timely submission of regulatory dossiers and tracking regulatory plans and quality assurance planning.
- Manage non-conformities, follow-up plans for CAPAs, document tracking and control in SAP, and prepare regulatory submissions to INVIMA and other regulatory entities.
- Lead the preparation and updating of quality agreements, manage regulatory and quality databases, and follow-up on regulatory processes with the factory.
- Provide technical and sanitary product documents, issue letters to customers, and review registration requests received in detail and provide appropriate responses and support to stakeholders.
Requirements
- Bachelor's degree in Pharmaceutical Chemistry, Bacteriology, Biomedical Engineering, or Chemical Engineering.
- Minimum 2 years of experience in Quality Assurance and Regulatory Affairs in the Medical Device and/or RDIV industry.
- Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
- Intermediate English language skills.
- Familiarity with ISO 13485 and/or ISO 9001-2015.
What We Offer
- An estimated salary of $80,000 - $110,000 per year, based on your qualifications and experience.
- A dynamic and innovative work environment, with opportunities for growth and professional development.
- A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
-
Regulatory Affairs Specialist
hace 1 mes
Bogotá, Bogotá D.E., Colombia Werfen A tiempo completoOverviewJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to support the implementation and execution of regulatory and quality plans, and perform any regulatory activities for products marketed by Werfen.About the Role:Collaborate with RAQA management to drive business objectives.E nsure compliance with RAQA record management...
-
Regulatory and Quality Assurance Specialist
hace 3 semanas
Bogotá, Bogotá D.E., Colombia Werfenlife Sa. A tiempo completoJob OverviewWerfenlife Sa. is a growing, family-owned, innovative company founded in 1966 in Spain. We are committed to delivering high-quality products that meet the needs of our customers.Job DescriptionWe are seeking a highly skilled Regulatory and Quality Assurance Specialist to join our team. The successful candidate will be responsible for supporting...
-
Regulatory Affairs Specialist
hace 4 semanas
Bogotá, Bogotá D.E., Colombia Coopervision A tiempo completoAbout CoopervisionCoopervision is a leading manufacturer of high-quality contact lenses and eye care products. We are dedicated to delivering innovative solutions that enhance the lives of our customers.Job SummaryWe are seeking an experienced Regulatory Affairs Specialist to join our team in Coopervision. This role will be responsible for ensuring...
-
Regulatory Affairs Specialist: Product Compliance Expert
hace 3 semanas
Bogotá, Bogotá D.E., Colombia Coopervision A tiempo completo**Job Overview**We are seeking a highly skilled Regulatory Affairs Specialist to join our team at CooperVision. This role will be responsible for ensuring compliance with regulatory requirements for our medical products.Salary: $80,000 - $110,000 per year, depending on experience and location.Job Description:The ideal candidate will have a strong background...
-
Bogotá, Bogotá D.E., Colombia Igc Pharma Sas A tiempo completoAbout IGC Pharma SASIGC Pharma SAS is a subsidiary of an NYSE-listed U.S. start-up clinical-stage pharmaceutical company based in Bogota, focusing on preventing and managing Alzheimer's and other CNS diseases.Role Overview: As a Regulatory Affairs Specialist, you will play a critical role in ensuring the successful planning and execution of clinical trials...
-
Regulatory Affairs Expert
hace 4 semanas
Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completoOverviewAt Medtronic, we pioneer healthcare technology to alleviate pain, restore health and extend life. Our team of 90,000+ passionate people experiment, create, build, improve and solve real-world problems.About the RoleThe Regulatory Affairs Specialist will lead regulatory activities for Latin America, ensuring compliance with regional regulations. This...
-
Regulatory Affairs Specialist
hace 5 días
Bogotá, Bogotá D.E., Colombia Werfenlife Sa. A tiempo completoJob Description:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Werfenlife Sa. This is an exciting opportunity for a motivated and experienced professional to support the implementation and execution of regulatory and quality plans.Key Responsibilities:Support RAQA management with a business focus, ensuring compliance with...
-
Bogotá, Bogotá D.E., Colombia Stryker Corporation A tiempo completoStryker Corporation is seeking a highly skilled Regulatory Affairs Specialist to join their team in Bogota D.C., Colombia. This is a full-time opportunity with a hybrid work arrangement.As a Senior Regulatory Affairs Specialist, you will be responsible for executing regulatory affairs activities in accordance with defined procedures and processes. This...
-
Senior Regulatory Affairs Professional
hace 7 días
Bogotá, Bogotá D.E., Colombia Stryker Corporation A tiempo completoStryker Corporation Job OpportunityWe are seeking a Senior Regulatory Affairs Specialist to join our team in Bogota D.C., Colombia.Estimated Salary: $60,000 - $80,000 per annum.About the RoleThis is a full-time position with hybrid work flexibility.The ideal candidate will have 4+ years of experience in regulatory affairs and a strong understanding of...
-
Regulatory Affairs Coordinator Expert
hace 1 semana
Bogotá, Bogotá D.E., Colombia Pfizer A tiempo completoPfizer seeks a skilled Regulatory Affairs Coordinator to join our team. This is a full-time opportunity based in Colombia - Bogota - Suba.The estimated salary for this position is $60,000 - $80,000 per annum, depending on experience and qualifications.About the RoleWe are looking for a highly motivated and detail-oriented individual to coordinate and execute...
-
Regulatory Affairs Expert
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Stryker Group A tiempo completoJob DescriptionWe are seeking a highly skilled Regulatory Affairs Expert to join our team at Stryker Group.About the Role:
-
Regulatory Affairs Specialist
hace 3 semanas
Bogotá, Bogotá D.E., Colombia Stryker Group A tiempo completo**Job Summary:**We are seeking an experienced Regulatory Affairs Specialist to join our Stryker Group team in LATAM. The successful candidate will be responsible for executing regulatory affairs activities, collecting and maintaining files on RAQA intelligence, and identifying the need for new regulatory procedures.**Key Responsibilities:**
-
Quality Assurance Expert
hace 1 semana
Bogotá, Bogotá D.E., Colombia Salve Consulting A tiempo completoJob Title: Quality Assurance ExpertAbout the Role:We are seeking a meticulous and detail-oriented individual to join our team as a Quality Assurance Expert. This role is pivotal in safeguarding the excellence of our products.Key Responsibilities:Conduct real-time evaluations of all company products to ensure they meet quality standards.Monitor the...
-
Software Quality Assurance Expert
hace 5 días
Bogotá, Bogotá D.E., Colombia Amadeus It Group A tiempo completoAbout the RoleWe are seeking a highly skilled Software Quality Assurance Expert to join our team at Amadeus It Group.Job DescriptionAs a Software Quality Assurance Expert, you will be responsible for ensuring the quality and reliability of our software products. This involves designing and implementing testing procedures, analyzing test results, and working...
-
Dermatology Regulatory Affairs Specialist
hace 1 mes
Bogotá, Bogotá D.E., Colombia Galderma A tiempo completoGalderma, a leading dermatology company, is seeking a highly skilled Regulatory Affairs Coordinator to join its team. This role is ideal for individuals passionate about advancing dermatology and making a meaningful impact on consumers' lives.In this position, you will be responsible for implementing regulatory programs, processes, and policies to support...
-
Bogotá, Bogotá D.E., Colombia International Flavors & Fragrances A tiempo completoAbout Us:International Flavors & Fragrances is a global leader in taste, scent, and nutrition, offering innovative solutions to our customers worldwide. We value diversity, inclusion, and collaboration, fostering an environment where every employee can thrive.Job Overview:We are seeking an experienced Regulatory Affairs Specialist to join our team in...
-
Regulatory Affairs Director
hace 1 mes
Bogotá, Bogotá D.E., Colombia Abbvie A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Abbvie. In this role, you will develop and execute regulatory strategies in alignment with Global and Affiliate Regulatory colleagues.Main Responsibilities:Provide strategic direction to support the development of compliant and competitive Regulatory programs.Manage...
-
Regulatory Affairs Professional with Dermatology Expertise
hace 3 semanas
Bogotá, Bogotá D.E., Colombia Galderma A tiempo completoJob Description:We are seeking a skilled Regulatory Affairs Coordinator to join our team at Galderma, the leading dermatology company. In this role, you will be responsible for implementing regulatory affairs programs, processes, and policies to support product regulatory activities.About Us:Galderma is a pure-play dermatology category leader, present in...
-
Evaluations Quality Assurance Expert
hace 1 semana
Bogotá, Bogotá D.E., Colombia Grow-Talent A tiempo completoGrow-Talent.com is partnering with a leading technology firm in Bogota, Colombia to recruit an Evaluations Quality Assurance Expert.Employment Type: Full-timeWork Model: On-siteBenefits: Competitive salary and private health insurance from day one.Job Description:The selected candidate will perform quality assessments of live casino products to ensure...
-
Bogotá, Bogotá D.E., Colombia Galderma A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Bogota, Colombia. As a key member of our regulatory affairs department, you will be responsible for implementing programs, processes, and policies to support regulatory activities related to product regulatory, CMC regulatory, and scientific writing.Key...