Regulatory Affairs Specialist
20 hours ago
The Regulatory Affairs Executive will play a critical role in ensuring that the company's products comply with all required national and international regulations and standards. This position involves working closely with various external regulatory authorities and stakeholders, and internal departments to provide expertise and support in the area of regulatory affairs management.
Key Responsibilities- Regulatory Compliance
- Ensure compliance with all applicable regulatory requirements for medical devices or biotechnology products.
- Prepare and submit regulatory documentation, including applications, reports, and amendments, to regulatory authorities such as the HSA, NEA, FDA, EMA, or other relevant bodies.
- Maintain up-to-date knowledge of regulatory requirements and changes in global regulations.
- 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.
- 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.
- Maintain accurate and organized regulatory files and documentation.
- Ensure all regulatory submissions and approvals are properly documented and archived.
- Collaborate with the Quality Assurance team to ensure regulatory compliance with quality control processes.
- Participate in internal and external audits as required.
- Work closely with internal 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.
- Identify and assess regulatory risks associated with product marketing and commercialization.
- Develop risk mitigation strategies to address regulatory challenges.
- Monitor and evaluate post-market safety data and adverse event reports.
- Ensure timely reporting of adverse events to regulatory authorities as required.
- Bachelor's degree in life sciences, pharmacy, biomedical engineering, or a related field;
- 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 ISO9001, ISO13485, FDA, CE, EMA 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.
- Willing to travel as required to attend regulatory meetings and conferences
- Certification in Regulatory Affairs (e.g., RAPS RAC)
- Attractive remuneration package
- Opportunities for professional development and growth
- Modern and vibrant work environment
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