Regulatory Affairs Professional
3 days ago
AITBIOTECH PTE. LTD. is a growing biotech company focusing on molecular diagnostics and automated diagnostics solutions.
We are seeking a highly skilled Regulatory Affairs Specialist to support the sales of our products and services.
The successful candidate will be responsible for regulatory activities, liaising with regulatory authorities, and collaborating with cross-functional departments to ensure timely implementation of document change requests.
Key Responsibilities:
- Responsible for regulatory activities and ensuring compliance with relevant regulations.
- Liaise with regulatory authorities and follow-up on application status.
- Collaborate with cross-functional departments to ensure timely implementation of document change requests.
- Develop and establish policies and standards that convey best practices in the company.
- Work closely with lab and sales teams to drive quality and business efficiencies and processes.
- Ensure products are registered in time for market launch.
- Maintain quality management systems and be responsible for all aspects of quality procedures, standards, and specifications with approval from Quality Management Representative (QMR).
- Manage document control process for Quality Management Systems in compliance with ISO 13485, GDPMDs, and any other standards as appropriate.
- Support quality management audits (internal & external) to verify that regulatory and quality requirements have been met and proper closure of non-compliance activities.
- Take leadership role in developing and implementing advanced quality principles, fostering a culture of continuous improvements to improve process control and quality yields.
- Keep up-to-date with changes in regulatory legislation and guidelines.
- Provide guidance and advice on approved procedures, standardization, and requirements associated with the document management system.
- Provide expert regulatory input to in-licensing evaluations and due diligence activities.
- Provide training to new staff on document management system and document management processes and procedures.
- Management of nonconformance, customer complaints handling, and supplier auditing, etc.
- Ability to manage multiple simultaneous activities in a rapidly changing environment.
Requirements:
- Bachelor's degree or Diploma holder, preferably in Biomedical Sciences, Biology, Biochemistry, Pharmacy, or Pharmacology.
- Min 3 years of working experience in managing regulatory of life science products or devices.
- Understanding in HSA requirements and product approval such as ISO 13485, CE-IVD is a must.
- Fluent English; excellent written and verbal communication skills.
- Proficient in Microsoft Office.
- Good interpersonal skills to frequently work with colleagues and team members, and advise others on compliance and regulatory matters.
- Excellent analytical skills Attention to detail.
- Pro-active and problem-solving attitude.
- Highly autonomous, yet with a profound team spirit.
Salary: Estimated SGD $80,000 - $120,000 per annum, depending on qualifications and experience.
-
Senior Regulatory Affairs Professional
7 days ago
Singapore BIOBOT SURGICAL PTE. LTD. Full timeAbout BIOBOT SURGICAL PTE. LTD.We are a leading medical device company committed to providing innovative solutions for the healthcare industry.Job Title: Senior Regulatory Affairs ExecutiveSalary: SGD 120,000 - SGD 180,000 per annumAbout the Role:We are seeking an experienced Senior Regulatory Affairs Executive to join our team in Singapore. As a key member...
-
Senior Regulatory Affairs Professional
7 days ago
Singapore BEATHCHAPMAN (PTE. LTD.) Full timeJob OverviewWe are seeking an experienced Regulatory Affairs professional to lead our registration efforts in Singapore and Southeast Asia. As a key member of our team, you will be responsible for driving regulatory approvals across the region.Company ProfileBeathChapman Pte Ltd is a reputable company with a strong presence in the Asian market. We offer a...
-
Regulatory Affairs Director
7 days ago
Singapore HAYS SPECIALIST RECRUITMENT PTE. LTD. Full timeAbout the RoleWe are seeking a highly experienced Regulatory Affairs Lead to join our team in Singapore. The ideal candidate will have at least 5 years of experience in food regulatory affairs management, preferably with expertise in AMER or EMEA region.The successful candidate will be responsible for developing and implementing regulatory strategies to...
-
Associate, Regulatory Affairs
4 weeks ago
Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full timeRoles & ResponsibilitiesAbout APACMedFounded in 2014, the Asia Pacific Medical Technology Association (APACMed) is the first and only regional MedTech association in APAC, representing medical technology manufacturers (multinational corporations as well as small and medium enterprises), and local industry associations across the region. We are fully...
-
Regulatory Affairs Specialist
5 days ago
Singapore HAYS SPECIALIST RECRUITMENT PTE. LTD. Full timeJob Title: Regulatory Affairs SpecialistThe company is a fast-growing food and beverages business with a strong presence across Asia.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with all applicable laws and regulations.Stay up-to-date on changes in regulatory requirements and translate them into actionable steps for...
-
Regulatory Affairs Specialist
1 month ago
Singapore IQVIA Full timeKey Responsibilities:Deliver regulatory projects on time and with a proactive approach, coordinating with in-country regulatory team leads.Core Competencies:Identify and interpret regulations, guidelines, and other pertinent information issued by regulatory agencies.Review scientific data, publications, and related papers to ensure compliance with...
-
Regulatory affairs lead
4 weeks ago
Singapore HAYS SPECIALIST RECRUITMENT PTE. LTD. Full timeYour new company Our client is a fast-growing food and beverages company, with a strong presence across Asia. They are looking for an experienced Regulatory Affairs Lead to help them grow their regulatory team here in Singapore. Your new role Below are some of the key responsibilities for the role: Develop and implement regulatory strategies to ensure...
-
Senior Regulatory Affairs Manager
3 weeks ago
Singapore SL-Human Resource Consultancy Pte Ltd Full timeSL-Human Resource Consultancy Pte Ltd is seeking a highly experienced Regulatory Affairs Director to oversee and manage all regulatory activities in Singapore.Estimated Salary: $120,000 - $180,000 per yearThis role will involve ensuring compliance with local and international regulations, developing regulatory strategies to support business objectives, and...
-
Regulatory Affairs Professional
10 hours ago
Singapore AITBIOTECH PTE. LTD. Full timeAITBIOTECH PTE. LTD., a growing biotech company focusing on molecular diagnostics and automated diagnostic solutions, is looking for a Regulatory Affairs Specialist to support product sales and services.Job OverviewThis role involves regulatory activities, liaising with authorities, and collaborating with cross-functional teams to ensure timely document...
-
Regulatory affairs coordinator
1 month ago
Singapore ResMed Inc Full timeRegulatory Affairs Coordinator Location: Singapore, Singapore Time Type: Full time Posted on: 5 Days Ago Job Requisition ID: JR_035534 The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the preparation of...
-
Regulatory Affairs Project Lead
1 day ago
Singapore PRESTIGE BIOPHARMA LIMITED Full timePrestige Biopharma Limited is seeking an experienced Regulatory Affairs Project Lead to join our team.About the RoleWe are looking for a highly skilled and motivated individual to lead regulatory affairs projects from submission to approval, ensuring timely delivery and quality results.The successful candidate will have at least 3-5 years of experience in...
-
Regulatory affairs coordinator
1 month ago
Singapore ResMed Inc Full timeRegulatory Affairs Coordinator Apply to locations: Singapore, Singapore Time type: Full time Posted on: 6 Days Ago Job requisition id: JR_035534 The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the...
-
Executive, regulatory affairs
1 week ago
Singapore B. Braun Melsungen AG Full timeYou’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency, and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in...
-
Regulatory Affairs Specialist
3 days ago
Singapore MTC CONSULTING PTE. LTD. Full timeJob Description:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at MTC Consulting Pte Ltd.About the Role:This is an exciting opportunity for a talented professional to play a key role in ensuring compliance with regulatory requirements for medical devices.About the Company:MTC Consulting Pte Ltd is a leading consulting firm...
-
Regulatory Affairs Specialist
3 days ago
Singapore NYPRAX PHARMA PTE. LTD. Full timeJob OverviewWe are seeking an experienced Regulatory Affairs Manager to join our team at NYPRAX PHARMA PTE. LTD.This is a challenging role that requires strong regulatory knowledge and excellent communication skills.The successful candidate will be responsible for coordinating and submitting documentation to the Health Sciences Authority, compiling client...
-
Global Regulatory Affairs Director
3 days ago
Singapore HAYS SPECIALIST RECRUITMENT PTE. LTD. Full timeRegulatory Affairs Lead - SingaporeHAYS SPECIALIST RECRUITMENT PTE. LTD.About the CompanyHAYS SPECIALIST RECRUITMENT PTE. LTD. is a leading recruitment agency in Singapore, specializing in placing top talent in various industries. As a pioneer and growing team, we offer regional exposure, fast-track career progression into management, and exciting...
-
Regulatory Affairs
5 days ago
Singapore INTEGRITY PARTNERS PTE. LTD. Full timeJob OverviewIntegrity Partners Pte. Ltd. is seeking a highly skilled Regulatory Affairs & Quality Assurance Executive to join their team. As a key member, you will play a crucial role in ensuring the company's medical devices comply with regulatory requirements across various markets.About the RoleThis 6-month contract position offers an exciting opportunity...
-
Regulatory Affairs Consultant
1 day ago
Singapore NYPRAX PHARMA PTE. LTD. Full timeOverviewNyprax Pharma Pte. Ltd., a rapidly expanding Regulatory Affairs Consultancy firm, seeks a skilled Regulatory Assistant to join our team.
-
Project manager, regulatory affairs
1 week ago
Singapore PRESTIGE BIOPHARMA LTD Full timeJOB FUNCTION Project Manager, Regulatory Affairs MAIN RESPONSIBILITIES Manage project submissions as assigned by Regulatory Affairs leadership Support the management of key projects, including execution, for submission, approval, and launch Review, prepare and author documents for regulatory submissions including clinical trial applications, marketing...
-
Regulatory Affairs Director
3 days ago
Singapore Solventum Full timeThank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...