JOB SUMMARY
The Regulatory Affairs Executive will play a critical role in ensuring that the company's products comply with all national and international regulations and standards. This position involves working closely with various departments, including research and development, quality assurance, and marketing, to provide regulatory expertise and support throughout the product lifecycle.
RESPONSIBILITIES
1. Regulatory Compliance:
- Ensure compliance with all applicable regulatory requirements for medical devices, pharmaceuticals, or biotechnology products.
- Prepare and submit regulatory documentation, including applications, reports, and amendments, to regulatory authorities such as the HSA, NEA, FDA, EMA, MHRA, or other relevant bodies.
- Maintain up-to-date knowledge of regulatory requirements and changes in global regulations
2. Product Registration and Approval:
- Assist in the preparation and submission of regulatory dossiers for new medical device registrations, renewals, and change notifications.
- Liaise with regulatory agencies to facilitate the approval process and address any queries or deficiencies.
- Liaise with regulatory representatives of various principal medical suppliers for information gathering and product regulatory updates.
3. Regulatory Strategy:
- Develop and implement regulatory strategies for new and existing products.
- Provide regulatory input and advice to project teams during product development to ensure regulatory compliance and timely market access.
4. Documentation and Record Keeping:
- Maintain accurate and organized regulatory files and documentation.
- Ensure all regulatory submissions and approvals are properly documented and archived.
5. Quality Assurance Support:
- Collaborate with the Quality Assurance team to ensure regulatory compliance of manufacturing and quality control processes.
- Participate in internal and external audits as required.
6. Cross-Functional Collaboration:
- Work closely with marketing, and other business units to ensure regulatory requirements are integrated into new product launch and commercialization plans.
- Provide regulatory training and guidance to internal teams as and when required.
7. Risk Management:
- Identify and assess regulatory risks associated with product marketing and commercialization.
- Develop risk mitigation strategies to address regulatory challenges.
8. Post-Market Surveillance:
- Monitor and evaluate post-market safety data and adverse event reports.
- Ensure timely reporting of adverse events to regulatory authorities as required.
REQUIREMENTS
- Bachelor’s degree in life sciences, pharmacy, biomedical engineering, or a related field. A master’s degree or higher is preferred.
- Minimum of 3 years of experience in regulatory affairs within the medical device, pharmaceutical, or biotechnology industry.
- Familiarity with relevant regulatory guidelines and standards, including FDA, CE, EMA, ISO, and other international regulations.
- Strong attention to detail and organizational skills.
- Excellent written and verbal communication skills.
- Ability to work independently and as part of a team.
- Strong problem-solving and analytical skills.
- Proficiency in Microsoft Office Suite.
ADDITIONAL REQUIREMENTS
- Ability to travel as needed to attend regulatory meetings and conferences.
- Certification in Regulatory Affairs (e.g., RAPS RAC) is an advantage.
BENEFITS
- Attractive remuneration package
- Opportunities for professional development and growth
- Five-day work week
- Medical benefits
