Compliance and Regulatory Coordinator

1 day ago

Taguig, National Capital Region, Philippines beBeeRegulatoryAffair Full time ₱400,000 - ₱800,000

Regulatory Affairs Coordinators play a pivotal role in ensuring compliance with regulatory requirements in a fast-paced environment. This opportunity at B. Braun Group is ideal for detail-oriented, highly organized professionals passionate about regulatory affairs.

The successful candidate will be responsible for coordinating and preparing regulatory submissions, maintaining and organizing regulatory documentation, tracking submission timelines, and supporting regulatory compliance activities. They will also collaborate with cross-functional teams to facilitate communication and support product registration and approval processes.

Key Responsibilities
  • Regulatory Submissions: Coordinate and prepare regulatory submissions (applications, notifications, registrations, and reports) to ensure timely and accurate completion.
  • Document Management: Maintain and organize regulatory documentation in electronic systems, ensuring accuracy, completeness, and accessibility for internal and external stakeholders.
  • Timeline Management: Track and monitor submission timelines, milestones, and deliverables to ensure compliance with regulatory requirements and internal deadlines.
  • Regulatory Compliance: Support regulatory compliance activities, including monitoring regulatory changes, assisting with audits/inspections, and implementing compliance measures.
  • Cross-Functional Collaboration: Collaborate with cross-functional teams and provide administrative support to facilitate communication, gather documentation, and support product registration and approval processes.
Required Skills and Qualifications
  • Bachelor's Degree: A Bachelor's degree in pharmacy or healthcare-related field preferred.
  • Experience: Minimum of 1-2 years of experience in regulatory affairs, quality assurance, or related field in the healthcare or medical device industry.
  • Regulatory Knowledge: Knowledge of regulatory requirements and guidelines, including FDA regulations, EU MDR, ISO standards, and international regulatory requirements preferred.
  • Organizational Skills: Strong organizational, communication, and interpersonal skills with the ability to manage multiple tasks and priorities effectively.
What We Offer
  • Group Term Life Insurance:
  • Medical and Optical Reimbursement:
  • Maternity Assistance:
  • Training and Development Programs:
  • Fun Team-Building Activities:

We value diversity, inclusivity, and respect in our work environment. Join us and contribute your unique perspective to our team

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