Regulatory Affairs Associate

Cochlear; Kuala Lumpur; On-site; MYR 55,000 - 75,000; Full time

Job summary

A leading medical device company in Kuala Lumpur is seeking a Regulatory Affairs Specialist to support regulatory submissions, product registrations, and compliance with international standards. The ideal candidate will have a Bachelor's degree in a related field and 2-3 years of relevant experience. Responsibilities include managing regulatory documentation, ensuring adherence to quality standards, and collaborating with cross-functional teams for successful product launches. This role offers an opportunity to contribute to regulatory strategy and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in science, Biomedical Engineering, or related discipline is required.
• 2-3 years of experience in medical device or pharmaceutical industry, ideally in Regulatory Affairs.
• Good understanding of regulatory submission processes and regulations.

Responsibilities

• Support preparation and maintenance of regulatory submissions and product registrations.
• Assist interpretation and application of medical device labelling standards.
• Compile and submit regulatory files and product license renewals.
• Support review and approval of clinical study documents and advertising materials.
• Identify opportunities for process improvement in compliance and documentation.

Skills

Strong organizational skills

Attention to detail

Excellent written and verbal communication

Analytical abilities

Problem-solving abilities

Team collaboration

Education

Bachelor's degree in science or Biomedical Engineering

Advanced degree or RACS certification

Job description

In this role, you will support the preparation and maintenance of regulatory submissions, product registrations, and renewals in alignment with company and authority requirements. You will contribute to the development of labelling requirements for instructions for use, packaging labels, and product information and coordinate labelling verification to ensure compliance with international standards and country-specific regulations.

Key Responsibilities

1. Labelling Compliance and Documentation

Assist interpretation and application of global and regional medical device labelling standards and regulations.

Support the development and maintenance of a central repository of labelling requirements.

Prepare and deliver labelling requirements specifications, verification reports, test protocols and traceability reports.

Support the management of the lifecycle and traceability of labelling requirements, including the associated change management processes.

2. Regulatory Strategy and Planning

Support the implementation of regulatory strategies and business plans to meet submission timelines.

Coordinate and align regulatory activities with marketing and product plans.

Maintain positive relationships with regulatory authorities and assist in organizing meetings and communications.

3. Regulatory Submissions and Approvals

Compile, submit, and maintain regulatory files, product license renewals, and annual registrations.

Prepare responses to regulatory authority queries and manage associated documentation.

Track and report submission statuses and ensure timely renewals and compliance.

Support the archiving and retrieval of regulatory documentation as required.

4. Cross-Functional and Compliance Support

Support the review and approval of clinical study documents, advertising materials, and product labelling.

Participate in audits and inspections, ensuring all documentation meets quality and regulatory standards.

Contribute to the assessment of product and design changes, non-conformances, and risk management activities.

Collaborate with regional teams to ensure consistent compliance across markets.

5. Quality, Safety, and Continuous Improvement

Adhere to internal quality and regulatory procedures.

Identify opportunities for process improvement.

Actively support workplace health and safety initiatives.

Qualifications and Experience

Minimum

Bachelor’s degree in science, Biomedical Engineering, or a related discipline.

Strong organizational skills and exceptional attention to detail.

Excellent written and verbal communication skills.

Proven ability to manage multiple projects and meet deadlines.

Demonstrated analytical and problem-solving abilities.

Experience working collaboratively with cross-functional teams.

Ideal

Advanced degree or RACS certification.

2–3 years of experience within the medical device or pharmaceutical industry, ideally in Regulatory Affairs.

Good understanding of regulatory submission processes and medical device regulations.

Proven experience in the preparation and management of regulatory documentation.

Familiarity with requirements management tools and verification processes and documentation.