
Regulatory Affairs
6 days ago
Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager. This is a newly created headcount in Singapore.
Regulatory Affairs & QMS Manager.
Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:
Regulatory Affairs & Compliance:
- Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
- Interpret and apply global medical device regulations and standards.
- Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East, etc.).
- Maintain regulatory intelligence and proactively communicate changes to the organization.
- Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
- Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).
Quality Management System (QMS):
- Serve as the QMS Management Representative as required by ISO 13485.
- Maintain and continuously improve the QMS to ensure ongoing compliance with ISO 13485, EU MDR and FDA 21 CFR Part 820.
- Lead internal audits, management reviews, and risk management activities.
- Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
- Monitor and report on QMS performance metrics and key quality indicators (KPIs).
- Ensure proper document control and change management processes are implemented.
- Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.
About the company:
- American startup with senior management team; based in US, Europe and Singapore
- Hybrid work arrangement – 2 days in office, 3 days working from home
- Excellent medical insurance coverage
- Good variable bonus structure
- Great working culture
- Excellent office location (Central – just beside MRT)
Interested applicants, kindly send in a copy of your updated resume in WORD document to stating your current and expected remuneration together with notice period required to current employer.
You can also contact Vincent Low for a confidential discussion at
EA Personnel Registration No: R1324700
-
Regulatory Affairs Specialist
2 weeks ago
Central Region, Singapore Reeracoen Singapore Pte Ltd Full time $60,000 - $120,000 per yearJob title: Regulatory Affairs SpecialistReference ID: 36639Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring...
-
Regulatory Affairs Executive
1 day ago
Central Region, Singapore Poli Medical Company Pte Ltd Full time $90,000 - $120,000 per yearKey Responsibilities:Regulatory Submissions & ApprovalsPrepare, compile, and submit product registration dossiers to HSA and other relevant regulatory authorities.Maintain up-to-date knowledge of Singapore's Health Sciences Authority (HSA) guidelines, ASEAN Common Technical Dossier (ACTD), and other regional requirements.Ensure timely approvals for new...
-
Regulatory Affairs Manager
1 day ago
Central Region, Singapore ALLIED SEARCH PTE. LTD. Full time $90,000 - $120,000 per yearOpportunities for professional developmentReputable organizationGood company benefitsAs an Regulatory Affairs Manager (Chinese Proprietary Medicine), you will be responsible for the following duties:Serve as the primary point of contact between the company and regulatory authorities (e.g., Health Sciences Authority) to oversee and support product...
-
Regulatory Affairs Executive
4 days ago
Central Singapore Emprego SG Full time**Location** - Singapore, Central Singapore**Job Type** - Permanent**Salary** - $4,000 - $7,000 Per Month**Date Posted** - 2 hours agoAdditional Details **Job ID** - 113486**Job Views** - 1Roles & Responsibilities **Our client is a Consumer Health MNC, one of the leading players in the sector. Due to business needs, they are now recruiting Regulatory...
-
Regulatory Affairs Specialist, Chemicals
1 week ago
Central Singapore Emprego SG Full time**Location** - Singapore, Central Singapore**Job Type** - Full Time**Salary** - $3,500 - $5,500 Per Month**Date Posted** - 1 hour agoAdditional Details **Job ID** - 103882**Job Views** - 1Roles & Responsibilities **Job Title: Regulatory Affairs Specialist, Chemicals** **Reports to: Sr Manager, Business Process Excellence** **Location: Marsiling,...
-
Senior Manager, Regulatory Affair
1 week ago
East Region, Singapore ALLIED SEARCH PTE. LTD. Full time $120,000 - $240,000 per yearCompetitive Remuneration PackageTelecommunication industryEast Working LocationAs a Senior Manager, Regulatory Affairs ( Telecom - Interconnection and Compliance), you will be responsible for the following duties:Track and analyze telecom regulatory developments, with a focus on interconnection, wholesale access, and competition frameworks.Monitor and ensure...
-
Senior Corporate Affairs
1 day ago
Central Region, Singapore ASEAN CABLESHIP PTE. LTD. Full time $90,000 - $120,000 per yearWe're Hiring: Senior Corporate Affairs / Admin ExecutiveDepartment: Corporate Affairs / AdministrationReporting to: Head of Corporate Affairs / AdminAre you an experienced professional with a passion for corporate governance, administration, and strategic coordination? Join our dynamic team as a Senior Corporate Affairs / Admin Executive and play a key role...
-
Assistant Manager, Medical Affairs
1 day ago
Central Region, Singapore ALLIED SEARCH PTE. LTD. Full time $90,000 - $120,000 per yearReputable OrganizationGreat Career OpportunityCompetitive Remuneration PackageAs a Assistant Manager (Medical Affairs) you will be responsible for the following duties:Administer credentialing and privileging processes for clinical staff, ensuring complete documentation, database management, and committee meeting support.Maintain and update daily and monthly...
-
Regulatory Manager, APAC
1 day ago
Central Region, Singapore Private Advertiser Full time $120,000 - $200,000 per yearThe primary role of the REGULATORY MANAGER, ASIA PACIFIC is to oversees the product registrations and regulatory pathways in Asia Pacific. And work with other stakeholders to create effective business and project implementation plans. He/she needs to ensure compliance with Asia Pacific regulations.In this role, you will influence key decision-making...
-
Associate Safety
2 days ago
Central Singapore BOEING Full timeAt Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We’re committed to fostering an environment for every teammate that’s welcoming, respectful and inclusive, with great opportunity for...