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Services

We understand that no two organisations are the same. Find out more about how we've customised our recruitment offerings to help clients across South East Asia meet their needs.

Read more
About Robert Walters Philippines

Since our establishment in 2016, our belief remains the same: Building strong relationships with people is vital in a successful partnership.

Learn more

Work for us

Our people are the difference. Hear stories from our people to learn more about a career at Robert Walters

Learn more

Senior Regulatory Affairs Specialist

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This Senior Regulatory Affairs Specialist role offers an exciting opportunity to support functions related to gaining market access for regulated products, including submissions, communications with regional and business teams, collection of materials, analysing and preparing responses on all governing agency actions. The successful candidate will be based in the vibrant city of Makati and will have the chance to work within a multicultural environment.

What you'll do:

As a Senior Regulatory Affairs Specialist, you will play a pivotal role in ensuring our client's products gain the necessary market access. You will be responsible for preparing, submitting, and managing regulatory applications required for product market approvals in the Philippines. Your role will also involve coordinating with local consultants and agents who support regulatory submissions. You will be expected to collate and prepare all materials, reports, and follow-ups with regulatory agencies regarding recall activities. Additionally, you will support post-market surveillance activities such as complaint investigations, FSCA, MDR etc. Your commitment to quality will be evident as you adhere to and improve processes and works.

  • Collaborate closely with local consultants and agents to facilitate timely and compliant regulatory submissions.
  • Conduct and facilitate rigorous internal and external audits of quality systems and design dossiers to uphold regulatory requirements.
  • Demonstrate a steadfast commitment to quality by adhering to established processes and continuously improving operational workflows.
  • Drive the end-to-end process of preparing, submitting, and managing regulatory applications required for product market approvals in the Philippines.
  • Enhance and maintain local submission processes while aligning them with global standards to ensure consistency and efficiency.
  • Oversee post-market surveillance activities, including thorough complaint investigations and regulatory reporting (FSCA, MDR, etc.), to safeguard product integrity and compliance.
  • Prepare comprehensive documentation and effectively communicate with regulatory agencies to support recall activities and ensure swift resolution.
  • Provide crucial support in developing and adapting processes and procedures to comply with evolving local statutory and regulatory mandates.

What you bring:

The ideal candidate for the Senior Regulatory Affairs Specialist role will bring a wealth of experience and knowledge in regulatory affairs, particularly within the medical device industry. You will have a Bachelor's Degree in a technical discipline such as Pharmacy, Medical Technology, Dentistry, Radiologic Technology, Engineering, Computer Science or Chemistry. Your experience will include Philippines FDA licensing and PNRI licensing. Your solid working knowledge and experience of Philippines regulations and standards applicable to medical device market clearance will be crucial in this role.

  • Certification as a Qualified Person in Industry Regulatory Affairs (QPIRA) by the Center for Device Regulation, Radiation Health, and Research is required.
  • Demonstrate an in-depth understanding and practical application of Philippines regulations and standards governing medical device market clearance.
  • Exhibit a structured and analytical approach to problem-solving, complemented by a deep appreciation for quality tools and techniques in regulatory compliance.
  • Exhibit outstanding proficiency in both verbal and written communication skills in English, with a strong emphasis on clarity and professionalism.
  • Hold a Bachelor's Degree in a technical discipline such as Pharmacy, Medical Technology, Dentistry, Radiologic Technology, Engineering, Computer Science, or Chemistry from an accredited institution.
  • Hands-on experience conducting audits based on ISO 9001, ISO 13485, and GP DMD standards, showcasing a thorough understanding of audit processes.
  • Possess a minimum of 2 years of dedicated experience in regulatory affairs within the medical device industry, with specific expertise in navigating Philippines FDA licensing and PNRI licensing processes.
  • Proven ability to successfully manage and secure regulatory approvals, including License to Operate (LTO) and Medical Device Establishment License, is highly advantageous.

What sets this company apart:

Our client is a global leader in their field, committed to innovation and excellence. They offer a dynamic and multicultural work environment that fosters creativity and teamwork. They believe in investing in their employees' professional development and provide opportunities for growth and advancement. Their commitment to quality and continuous improvement sets them apart from other companies in the industry.

What's next:

Ready to take your career to the next level? Apply now!

Apply today by clicking on the link provided. Don't miss out on this exciting opportunity!

Due to the high volume of applications we are experiencing, our team will only be in touch with you if your application is shortlisted.

Contract Type: FULL_TIME

Specialism: Human Resources

Focus: HR Business Partner

Industry: Science and Research

Salary: Negotiable

Workplace Type: On-site

Experience Level: Associate

Location: Makati

Job Reference: X34UI2-7C73A3E3

Date posted: 27 June 2024

Consultant: Shinta Amalia

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