
Global Regulatory Affairs Expert
3 days ago
This role involves establishing and managing regulatory submission timelines for both new and existing products across key global markets. The incumbent will prepare and file global medical device applications and amendments, ensuring timely market access.
The Regulatory Compliance Specialist will engage with regulatory authorities and distribution partners to support product registrations. They will author and maintain EU MDR-compliant technical documentation, including notifications of change, and lead all EU regulatory initiatives.
Key responsibilities include conducting global regulatory impact assessments for product and manufacturing changes through the document control process; preparing and submitting required regulatory updates.
The successful candidate will act as the regulatory representative on cross-functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
They will interpret and apply international regulations, standards, and directives to ensure ongoing global compliance.
Additional responsibilities include reviewing and approving product labeling to ensure compliance with global regulatory requirements. The incumbent will also support and participate in inspections and audits conducted by global regulatory authorities.
Requirements- Minimum 5 years of experience
- Fluent English
-
Regulatory Affairs Expert
2 weeks ago
Singapore beBeeRegulatory Full time $120,000 - $150,000Regulatory Affairs ExpertAs a Regulatory Affairs Expert, you will play a pivotal role in ensuring our products meet the required legislative standards in Singapore and Malaysia.The ideal candidate will have a strong understanding of regulatory requirements and submission processes in the specified markets.Key Responsibilities:Direct and support regulatory...
-
Regulatory Affairs Expert
7 days ago
Singapore beBeeExpertise Full timeWe are seeking a highly skilled Regulatory Affairs Expert to ensure compliance with regulatory requirements for pharmaceutical product development, approval, and marketing globally.Key Responsibilities:Manage submission and approval processes for applications such as Manufacturing License Application (MLA), Technical/SiteJob Requirements:Advanced degree in...
-
Regulatory Affairs Director
1 week ago
Singapore PharmEng Technology Full time**Regulatory Affairs Director** Join a leading global organization as a **Regulatory Affairs Director**, shaping regulatory strategies across multiple regions. This high-impact role ensures compliance, drives regulatory approvals, and collaborates with senior leadership and health authorities worldwide. **Key Responsibilities**: Develop and implement...
-
Global Regulatory Affairs Manager
3 days ago
Singapore beBeeRegulatory Full time $150,000 - $200,000Regulatory Affairs Specialist Job OverviewThis is a key role within the organization responsible for all aspects of regulatory responsibilities in Singapore and Malaysia.The specialist will combine knowledge of scientific, regulatory, and business issues to enable products to meet required legislations in applicable markets. This includes directing and...
-
Head of Regulatory Affairs
6 days ago
Singapore REGASK PTE. LTD. Full time**OUR COMPANY** We, at RegASK are a high growth global RegTech company leveraging technology and global network of experts to revolutionize regulatory intelligence, serving the LifeSciences (MedTech, CROs, Pharma) and FMCG industries (Food, Personal Care). RegASK team is highly diverse with more than 10 nationalities across 3 continents, entrepreneurial and...
-
Regulatory Affairs Expert
4 days ago
Singapore beBeeRegulatory Full time $120,000 - $200,000Job DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team. This role will ensure regulatory compliance and execute robust quality assurance practices in the Asia Pacific region.Key ResponsibilitiesDevelop and execute regional regulatory strategies for medical devices, ensuring compliance with country-specific laws and...
-
Global Regulatory Affairs Professional
4 days ago
Singapore beBeeRegulatory Full time $90,000 - $120,000Job Title: Global Regulatory Affairs SpecialistWe are seeking a highly skilled Global Regulatory Affairs Specialist to join our team. This role will be responsible for efficiently obtaining and maintaining product registrations in APAC countries, working closely with distributors, consultants, regulators, and HOYA affiliates.This position requires...
-
Global Regulatory Affairs Specialist
7 days ago
Singapore beBeeRegulatory Full time**Job Overview**Regulatory affairs specialists are responsible for ensuring compliance with global regulatory requirements.**Key Responsibilities**Develop and manage regulatory submission timelines for new and existing products across key markets.Prepare and file global medical device applications and amendments to ensure timely market access.Collaborate...
-
Manager, Regulatory Affairs Apac
5 days ago
Singapore Johnson & Johnson Full time**Job Function**: Regulatory Affairs Group **Job Sub Function**: Regulatory Affairs **Job Category**: Professional **All Job Posting Locations**: Hong Kong, Hong Kong, Hsinchu City, Hsinchu County, Taiwan, North Ryde, New South Wales, Australia, Petaling Jaya, Selangor, Malaysia, Singapore, Singapore **Johnson & Johnson is currently seeking a Manager,...
-
Global Regulatory Affairs Lead
7 days ago
Singapore PHARMACEUTICAL RESEARCH ASSOCIATES SINGAPORE PTE. LTD. Full timeICON is offering an opportunity to work within our dedicated, talented, supportive and friendly Global Regulatory Clinical Services (GRCS) team in clinical trials. The GRCS team has been in operation for 25+ years and comprises more than 400 regulatory professionals located in 48 countries, managing submissions in 60+ countries. As part of the GRCS team,...