FDA Regulatory Affairs Officer
1 week ago
Posted 2 days ago and deadline of application is on 30 Jan
Job DescriptionFDA Regulatory Affairs Officer
The FDA Regulatory Affairs Officer will be in-charge of all activities related to the licensing and registration of the company's present and future products (medical equipment, devices, accessories, supplies and related products), and in charge of the company itself to regulatory bodies in the Philippines, including but not limited to the Department of Health (DOH) and the Food and Drug Administration (FDA). He/she shall ensure that the company complies with all legal requirements and is able to continue selling and marketing of products to all its target customers nationwide.
In the performance of the job, the FDA Regulatory Affairs Officer is expected to communicate consistently with regulatory authorities, as well as with the company's suppliers and customers. He/she is also expected to assist in other administration, sales and marketing activities of the company.
Minimum Qualifications- Be a graduate of medical and engineering allied courses with PRC license
- Be able to grasp highly technical product information and able to communicate the same in simple terms to the medical profession.
- Highly organized and very keen into details of FDA requirements.
- Have advanced communication skills and with good command of English language.
- Have high energy, positive outlook and professional bearing and natural understanding of professional business ethics.
MEDEV is dedicated to elevating the standard of healthcare in the Philippines by being a leading force in the enhancement of medical equipment quality and ensuring exceptional after-sales support. Our commitment revolves around offering healthcare providers specialized equipment tailored to meet clinical and diagnostic requirements, ensuring optimal utilization. With a focus on fostering long-term partnerships, we uphold a unique sense of integrity in our operations. Our employees are held to the highest standards of business ethics, contributing to the loyalty of customers who repeatedly choose us as their trusted source. Over our two decades of existence, we have established ourselves as a premier provider of equipment for peripheral vascular testing, ultrasound imaging, 2D-echocardiography, stress ECG testing, holter ECG, Ambulatory BP monitoring, laser dermatology, and more. Recognized for having the largest inventory of backup parts and units, delivering top-notch after-sales training and support, and maintaining a highly responsive service operation, we take pride in our industry reputation. In recent years, we expanded our product offerings to include critical care, neuro-psychiatry, and radiology. Presently, we can provide a comprehensive range of radiology equipment, including x-rays, mammography systems, CT scanners, and MRI machines. Our inventory extends to equipment for the ICU and emergency department, such as patient monitors, infusion/syringe pumps, and defibrillators. Additionally, we stand out as one of the few providers of EEG machines and Transcranial Magnetic Stimulation equipment in the country. MEDEV is dedicated to continuously evolving and meeting the diverse needs of the healthcare landscape in the Philippines.
#J-18808-Ljbffr-
Head of Regulatory Affairs
6 days ago
Paranaque City, Calabarzon, Philippines Faberco Life Sciences Incorporated Full timeDirect message the job poster from Faberco Life Sciences IncorporatedHR and Admin Officer at Faberco Life Sciences Inc.PRIMARY OBJECTIVEThe Regulatory Affairs Head is responsible for leading and managing the Regulatory Affairs team in ensuring that all pharmaceutical products comply with applicable regulations in the Philippines. This role involves...
-
Regulatory Affairs Director
6 days ago
Paranaque City, Calabarzon, Philippines Faberco Life Sciences Incorporated Full timeThe Regulatory Affairs Director at Faberco Life Sciences Incorporated is responsible for leading the company's regulatory efforts to ensure compliance with applicable laws, regulations, and standards in the pharmaceutical industry.About the RoleThis is a challenging and rewarding opportunity for an experienced professional to lead the development and...
-
Regulatory Affairs Specialist
6 days ago
Cavite City, Calabarzon, Philippines HR Primo Management Services Full time**Role Responsibilities**As a Regulatory Affairs Specialist at HR Primo Management Services, you will be responsible for overseeing the company's regulatory compliance program. This includes developing, implementing, and monitoring compliance policies, managing documentation, and ensuring cross-functional collaboration to mitigate compliance risks.You will...
-
Regulatory Affairs Specialist
4 days ago
Cavite City, Calabarzon, Philippines RCX RECRUITMENT INC. Full timeRegulatory Affairs Specialist - Quality Job Summary:We are looking for a Regulatory Affairs Specialist - Quality to join our team at RCX RECRUITMENT INC. The successful candidate will be responsible for ensuring the quality and regulatory compliance of our products and services.Main Responsibilities:Providing FDA data and information to US CustomsWorking...
-
Director of Regulatory Strategy
6 days ago
Paranaque City, Calabarzon, Philippines Faberco Life Sciences Incorporated Full timeFaberco Life Sciences Incorporated is seeking an experienced Director of Regulatory Strategy to join its team. As a key member of the regulatory team, you will be responsible for developing and implementing effective regulatory strategies to ensure compliance with FDA Philippines regulations and international standards.About the PositionThe ideal candidate...
-
Head of Compliance and Regulatory
6 days ago
Paranaque City, Calabarzon, Philippines Faberco Life Sciences Incorporated Full timeFaberco Life Sciences Incorporated seeks an experienced Head of Compliance and Regulatory to join its team. This key role will be responsible for ensuring that all pharmaceutical products comply with relevant laws, regulations, and standards in the Philippines.About the PositionThe ideal candidate will have a strong background in Regulatory Affairs,...
-
regulatory affairs quality specialist 47338
4 days ago
Cavite City, Calabarzon, Philippines RCX RECRUITMENT INC. Full timeResponsibilities:Provides FDA data and information to US Customs.Works with FDA and US Customs to resolve shipments placed on hold.Writes Health Risk Assessments for Nonconforming products, customer complaints, and MDRs.Supports Sales and Marketing to resolve any FDA compliance questions or concerns from customers.Interprets and applies regulatory guidelines...
-
Pharmaceutical Regulatory Specialist
5 days ago
Paranaque City, Calabarzon, Philippines Rudolf Lietz, Inc. Full timeJob OverviewRudolf Lietz, Inc. is seeking a skilled Pharmaceutical Regulatory Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with government requirements from the FDA, PDEA, DDB, and BAI.Key Responsibilities:Maintenance of licenses and compliance with government...
-
Regulatory Affairs Pharmacist
5 days ago
Paranaque City, Calabarzon, Philippines Rudolf Lietz, Inc. Full timeAbout the RoleWe are seeking a highly motivated Compliance and Quality Assurance Pharmacist to join our team at Rudolf Lietz, Inc. As a Compliance and Quality Assurance Pharmacist, you will play a critical role in ensuring that our products meet regulatory requirements.Key Responsibilities:Renewal of licenses and compliance with government...
-
Regulatory Compliance Specialist
4 days ago
Cavite City, Calabarzon, Philippines RCX RECRUITMENT INC. Full timeAbout the Role:We are seeking a highly skilled Regulatory Compliance Specialist to join our team at RCX RECRUITMENT INC.The successful candidate will be responsible for providing FDA data and information to US Customs, working with FDA and US Customs to resolve shipments placed on hold, and writing Health Risk Assessments for Nonconforming products, customer...
-
Quality and Regulatory Professional
4 days ago
Cavite City, Calabarzon, Philippines RCX RECRUITMENT INC. Full timeJob Overview:We are looking for a Quality and Regulatory Professional to join our team at RCX RECRUITMENT INC. As a key member of our team, you will be responsible for ensuring the quality and regulatory compliance of our products and services.Responsibilities:Providing FDA data and information to US CustomsWorking with FDA and US Customs to resolve...
-
Regulatory Compliance Expert
6 days ago
Cavite City, Calabarzon, Philippines HR Primo Management Services Full time**Job Overview**At HR Primo Management Services, we are seeking a highly skilled Regulatory Compliance Expert to oversee our company's adherence to regulatory requirements. This role involves developing, implementing, and monitoring compliance policies, managing documentation, and ensuring cross-functional collaboration to mitigate compliance risks.The ideal...
-
Pharmaceutical Product Lead
6 days ago
Paranaque City, Calabarzon, Philippines Faberco Life Sciences Incorporated Full timeWe are seeking an experienced Pharmaceutical Product Lead to join our team at Faberco Life Sciences Incorporated. As a key member of the regulatory team, you will be responsible for ensuring that all pharmaceutical products comply with relevant laws, regulations, and standards in the Philippines.About the RoleThe ideal candidate will have a strong background...
-
Regulatory Compliance Officer
1 day ago
Paranaque City, Calabarzon, Philippines Rudolf Lietz, Inc. Full timeJob DescriptionThe Pharmaceutical Group requires a skilled Regulatory Pharmacist to ensure compliance with government regulations and maintain the quality of our pharmaceutical products. The successful candidate will be responsible for license renewals, regulatory submissions, and maintenance of the sample cabinet.In addition to these responsibilities, the...
-
Government Regulatory Pharmacist
1 day ago
Paranaque City, Calabarzon, Philippines Rudolf Lietz, Inc. Full timeWhat We're Looking ForWe are seeking a highly skilled and motivated Regulatory Pharmacist to join our team. The successful candidate will have a strong background in pharmacy and regulatory affairs, with a minimum of 1-2 years of experience in areas of QA/QC and/or regulatory in the pharmaceutical manufacturing/trading/distribution industry.You will be...
-
Regulatory Affairs Professional
2 hours ago
Cavite City, Calabarzon, Philippines Gencys Digital Trading Full timeWe are seeking a Regulatory Affairs Professional to join our team at Gencys Digital Trading. As a key member of our compliance department, you will be responsible for ensuring the organization's compliance with relevant laws and regulations.About the RoleYou will work closely with the management team to develop and implement compliance strategies.You will...
-
Regulatory Pharmacist
5 days ago
Paranaque City, Calabarzon, Philippines Rudolf Lietz, Inc. Full timeShareJob DescriptionGovernment Mandated BenefitsInsurance Health & WellnessHealth InsuranceEmployee Discount, Parking Space, Pet Friendly WorkplaceBereavement Leave, Maternity & Paternity Leave, Sick Leave, Vacation LeaveDescriptionThe Pharmacist has multiple functions. For regulatory work, he/she is responsible for the renewal of licenses and compliance...
-
Product Officer
2 days ago
Paranaque City, Calabarzon, Philippines Fourtify Inc Full timeDuties:* Oversee product development, ensuring FDA compliance for safety, labeling, and ingredients.* Collaborate with cross-functional teams (R&D, marketing, ops) for product launches.* Manage demand forecasting and inventory planning, ensuring alignment with production needs.* Ensure product quality and safety through continuous monitoring and quality...
-
Compliance and Quality Assurance Expert
4 days ago
Cavite City, Calabarzon, Philippines RCX RECRUITMENT INC. Full timeCompliance and Quality Assurance Expert Job Description:We are seeking a Compliance and Quality Assurance Expert to join our team at RCX RECRUITMENT INC. The successful candidate will be responsible for ensuring the quality and regulatory compliance of our products and services.Main Responsibilities:Providing FDA data and information to US CustomsWorking...
-
Compliance Manager
6 days ago
Cavite City, Calabarzon, Philippines HR Primo Management Services Full timeDirect message the job poster from HR Primo Management ServicesAs a Compliance Manager, you are responsible for overseeing the company's adherence to regulatory requirements, including FDA, ISO standards, and other industry regulations. The role involves developing, implementing, and monitoring compliance policies, managing documentation, and ensuring...