Regulatory Affairs Officer

Job description

Are you passionate about Regulatory Affairs Officer and its processes? If so, this opportunity could be for you! Join us at B. Braun, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare! As a Regulatory Affairs Officer at B. Braun you plays a vital role in ensuring compliance with regulatory and pharmacovigilance (PV) requirements. This position is responsible for supporting regulatory submissions, maintaining regulatory documentation, ensuring adherence to safety reporting obligations, and coordinating with regulatory authorities and internal teams. The role requires strong organizational skills, attention to detail, and collaboration with cross-functional teams, including Regulatory Affairs, Quality Assurance, Global Pharmacovigilance & Patient Safety (GPVS), and Manufacturing. Your key responsibilities: Regulatory Compliance & Submissions – Prepare, review, and submit accurate regulatory filings, maintain documentation, and ensure timely renewals in line with local and international regulations. Process & Audit Management – Organize regulatory records, manage document control, and support internal/external audits and inspections, implementing corrective actions when needed. Cross-Functional Collaboration – Work closely with R&D, QA, Clinical Affairs, and Marketing teams to align regulatory strategies and act as liaison with regulatory agencies. Pharmacovigilance Oversight – Establish and maintain local PV systems, ensure timely reporting of adverse events, and coordinate safety monitoring with global PV teams. Safety Compliance & Communication – Monitor evolving drug safety regulations, conduct training, manage audits, and serve as primary contact for urgent safety-related inquiries and communications. What you will bring to the team: Bachelor’s degree in a scientific, technical, or healthcare-related field; advanced degree or regulatory certification preferred Registered pharmacist is required for this role 5–7 years of experience in regulatory affairs, quality assurance, or related roles within healthcare or medical devices Strong knowledge of FDA regulations, EU MDR, ISO standards, and global regulatory requirements Excellent organizational, analytical, and problem-solving skills with ability to manage multiple priorities Effective communicator with strong interpersonal skills and proficiency in Microsoft Office and regulatory software What sets B. Braun apart? B. Braun is dedicated to protecting and improving global health. Established in the Philippines in 1985, it leverages over 185 years of innovation from its parent company, B. Braun Melsungen AG, which operates in 64+ countries. Initially focused on sutures and disposables, B. Braun Philippines has grown over 39 years to employ more than 800 sales and service professionals. We now offer advanced dialysis treatments and a broad range of healthcare solutions, including infusion devices, surgical instruments, sutures, regional anaesthesia, haemodialysis machines, disposables, value-added drugs, and clinical nutrition, delivering comprehensive patient care across the country. What can we offer you? Group Term life Insurance Medical and Optical Reimbursement Maternity assistance Training and development programs Engage in fun activities and team building events What’s next? Once you click on the link to Apply, you will be directed to update your personal information and submit your CV. Our Talent Acquisition team will carefully review your application, and if you pass the CV screening you will be invited for the first interview. We ask you to conduct two interviews, one in person and one remotely. If you stand out and meet our requirements, we will present you with an offer and guide you through our seamless onboarding process. Join us and be part of something extraordinary! We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are. To find out more about our commitment to diversity click here Check us out on Social Media! B. Braun Group LinkedIn B. Braun Group YouTube To find out more about B. Braun Philippines here