Manager - Regulatory Affairs

Are you passionate about
regulatory affairs in medical devices
? 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 Manager
at B. Braun you will play a critical role in ensuring the organization's compliance with regulatory requirements and facilitating the timely and successful registration and approval of medical products. The incumbent will manage regulatory submissions, communicate with regulatory agencies, and provide regulatory guidance and support to cross-functional teams. This role requires strong regulatory knowledge, project management skills, and the ability to navigate complex regulatory landscapes.

Your key responsibilities:

• Ensure the organization's compliance with regulatory requirements and facilitating the timely and successful registration of medical products.
• Manage regulatory submissions, communicate with regulatory agencies, and provide regulatory guidance and support to cross-functional teams. This role requires strong regulatory knowledge, project management skills, and the ability to address complex regulatory matters.
• Develop and implement regulatory strategies to support the registration, approval, and maintenance of medical B. Braun products in compliance with applicable regulations and guidelines.
• Continuously monitor the regulatory landscape (i.e., changes in regulatory requirements, standards, trends, etc.) assess any potential impact on the organization, and provide recommendations for compliance strategies and actions.
• Ensure compliance with regulatory requirements throughout the product lifecycle, including development, distribution, and post-market surveillance.
• Acts as the Local Safety Officer (LSO): Perform the designated tasks and responsibilities according to Global standards and local regulations.
• Communicate with regulatory agencies to facilitate the review and approval process, address questions or concerns, and obtain regulatory clearances or approvals.
• Coordinate and support product registration and approval activities, including the preparation and submission of regulatory dossiers, technical documents, and quality records, in accordance with local regulations and requirements.
• Serve as a regulatory subject matter expert and provide guidance and support to internal stakeholders on regulatory matters, including interpretation of regulations, standards, and guidelines.
• Provide regulatory training and education to internal stakeholders to enhance awareness and understanding of regulatory requirements, processes, and responsibilities.

What you will bring to the team:

• Bachelor's degree in a scientific, technical, or healthcare-related field required; Advanced degree preferred.
• Minimum of 5-7 years of experience in regulatory affairs in the pharmaceutical and medical device industry, with at least 3 years in a managerial or leadership role.
• Strong knowledge of regulatory requirements and guidelines, including FDA regulations, , and international regulatory requirements.
• Experienced in preparing and submitting regulatory filings, managing regulatory submissions, and interacting with regulatory agencies.
• Excellent project management, communication, and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
• Ability to analyze complex regulatory issues, develop innovative solutions, and drive regulatory strategies to achieve business objectives.
• Proficiency in regulatory affairs software, document management systems, and Microsoft Office Suite.

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