Regulatory Affairs Coordinator

Are you detail-oriented, highly organized, and passionate about ensuring regulatory compliance in a fast-paced environment? 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 Coordinator
at B. Braun, you will play a vital role in role in supporting regulatory compliance efforts and facilitating the efficient management of regulatory activities. You will assist with regulatory submissions, track regulatory documents, and support regulatory compliance initiatives. This role requires strong organizational skills, attention to detail, and the ability to work effectively in a dynamic and fast-paced environment.

Your key responsibilities:

• Coordinate and prepare regulatory submissions (applications, notifications, registrations, and reports) to ensure timely and accurate completion.
• Maintain and organize regulatory documentation in electronic systems, ensuring accuracy, completeness, and accessibility for internal and external stakeholders.
• Track and monitor submission timelines, milestones, and deliverables to ensure compliance with regulatory requirements and internal deadlines.
• Support regulatory compliance activities, including monitoring regulatory changes, assisting with audits/inspections, and implementing compliance measures.
• Collaborate with cross-functional teams and provide administrative support to facilitate communication, gather documentation, and support product registration and approval processes.

What you will bring to the team:

• Bachelor's degree in pharmacy or healthcare-related field preferred.
• Minimum of 1-2 years of experience in regulatory affairs, quality assurance, or related field in the healthcare or medical device industry.
• Knowledge of regulatory requirements and guidelines, including FDA regulations, EU MDR, ISO standards, and international regulatory requirements preferred.
• Strong organizational, communication, and interpersonal skills with the ability to manage multiple tasks and priorities effectively.

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

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To find out more about B. Braun Philippines here