Senior Regulatory Affairs Executive
1 month ago
Job Description – Senior Regulatory Affairs Executive
- Drafting, compiling and maintaining of technical documents to ensure compliance to the applicable domestic and international regulations and standards , specifically EU MDR 2017/745
- Prepare and submit regulatory technical documentations to regulatory authorities for new registrations, renewal and change notification (eg US FDA, SG HSA, AUS TGA etc)
- Ensure compliance with applicable regulatory requirements and standards for medical device.
- Work closely with internal team for documentation and information gathering.
- Liase with various regulatory authorities and authorised representatives on requirements needed to facilitate product approval and address any deficiencies and queries.
- Support in adverse event reporting, report adverse event regulatory authorities in relevant countries within the stipulated timeline, when required.
- Participate in internal / external audits as part of the audit team (including supplier audit)
- Maintain up-to-date knowledge of regulatory requirements and changes
- Ensure post-market surveillance obligations are complied with regulations
- Any other ad-hoc assigned
Qualification Requirement
- Bachelor’s degree in biological science, biological engineering, pharmacy or related field;
- 4-5 years of experience in medical device regulatory affairs with experience in FDA 510(k) or CE marking
- Familiar with relevant regulatory guidelines and standards such as ISO 13485, EU MDR 2017/745
- Strong attention to detail and organization skills;
- Ability to work independently and as part of a team;
- Strong problem-solving and analytical skills;
- Excellent written and verbal communication skills
Tell employers what skills you have
Annual Reports
CE marking
Leadership
FDA
Ability To Work Independently
Regulatory Affairs
Healthcare
Audits
Communication Skills
Change Control
Regulatory Submissions
-
Senior Regulatory Affairs Professional
3 weeks 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 Specialist, Regulatory Affairs
4 days ago
Singapore INTERNATIONAL FLAVORS & FRAGRANCES (GREATER ASIA) PTE. LTD. Full timeRoles & ResponsibilitiesJob SummaryThis position will be responsible for the management of product registrations, product compliance or product safety and risk assessment for Animal Nutrition & Health. IFF applies expert science to advance market-driven, healthy, and sustainable solutions for the food/feed, beverage, dietary supplements, and many other...
-
Senior Specialist, Regulatory Affairs
3 weeks ago
Singapore INTERNATIONAL FLAVORS & FRAGRANCES (GREATER ASIA) PTE. LTD. Full timeRoles & ResponsibilitiesJob SummaryThis position will be responsible for the management of product registrations, product compliance or product safety and risk assessment for Animal Nutrition & Health. IFF applies expert science to advance market-driven, healthy, and sustainable solutions for the food/feed, beverage, dietary supplements, and many other...
-
Executive, regulatory affairs
3 weeks 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...
-
Senior Regulatory Affairs Leader
1 month ago
Singapore Mondelēz International Full timeAbout Mondelēz InternationalMondelēz International is a global snacking powerhouse with a diverse portfolio of beloved brands. Headquartered in Singapore, our Asia, Middle East, and Africa (AMEA) region comprises six business units, employs over 21,000 people, and operates in more than 27 countries.Job SummaryWe are seeking an experienced Senior Manager to...
-
Senior regulatory affairs specialist
4 weeks ago
Singapore Airswift Full timeSenior Regulatory Affairs Specialist (1-Year Contract) Location: Singapore (On-Site) We are seeking a Senior Regulatory Affairs Specialist to join a dynamic global healthcare organization specializing in innovative diagnostic solutions. This role focuses on regulatory submissions and license management across high-growth markets in the Asia-Pacific region....
-
Singapore Mondelēz International Full time**Lead Regulatory Affairs in South East Asia**Mondelēz International seeks an experienced Senior Regulatory Affairs Manager to lead the scientific and regulatory affairs strategy for the South East Asia Business Unit.**Salary:** $120,000 - $180,000 per annum (dependent on location and experience)This is a fantastic opportunity to join a global company with...
-
Regional Regulatory Affairs Executive
1 week ago
Singapore A. MENARINI ASIA-PACIFIC HOLDINGS PTE. LTD. Full timeRoles & ResponsibilitiesPOSITION SUMMARY:The Regional Regulatory Executive will be a key member of the team responsible for new registration submission and management of product life cycle of pharmaceutical products in Asia Pacific.KEY RESPONSIBILITIES: Regional Lead in registration submissions of pharmaceutical products in APAC regions: ASEAN, Greater...
-
Regional Regulatory Affairs Executive
2 weeks ago
Singapore A. MENARINI ASIA-PACIFIC HOLDINGS PTE. LTD. Full timeRoles & ResponsibilitiesPOSITION SUMMARY:The Regional Regulatory Executive will be a key member of the team responsible for new registration submission and management of product life cycle of pharmaceutical products in Asia Pacific.KEY RESPONSIBILITIES: Regional Lead in registration submissions of pharmaceutical products in APAC regions: ASEAN, Greater...
-
Senior Regulatory Affairs Project Manager
3 weeks ago
Singapore PRESTIGE BIOPHARMA LIMITED Full timeWe are seeking a highly skilled and experienced Senior Regulatory Affairs Project Manager to join our team at Prestige Biopharma Limited.About the RoleThis is an exciting opportunity for a motivated individual to lead regulatory project submissions, manage key projects, and collaborate with stakeholders to ensure project timelines are met.As a Senior...
-
SG, SINGAPORE, VIRTUAL Solventum Full timeOverviewSolventum, a pioneer in game-changing innovations at the intersection of health, material, and data science, is seeking an experienced Regulatory Affairs Director to lead our APAC team. As a key contributor to governance decisions, you will play a strategic role in shaping our regulatory strategy.Job DescriptionThe Regulatory Affairs Director will...
-
APAC Regulatory Affairs Leader
4 hours ago
SG, SINGAPORE, VIRTUAL Solventum Full timeAt Solventum, we are driven by a passion for creating innovative solutions that improve lives. As the new company born from 3M Health Care, we continue to pioneer game-changing innovations at the intersection of health, material, and data science.About the RoleWe are seeking a highly experienced Regulatory Affairs Director to lead our APAC team, driving...
-
Senior vice president, public affairs, japac
2 weeks ago
Singapore Page Executive Full timeJoin a prestigious global leader in medical technology Work with a team of industry leaders driving innovation About Our Client Join our client, a leading company in the Med Tech industry, as they seek a Senior Vice President of Public Affairs to provide strategic leadership across Japan, Greater China, and the Asia-Pacific region. This pivotal role will...
-
Senior Regulatory Affairs Specialist
3 weeks ago
Singapore MORGAN PHILIPS SINGAPORE PTE. LTD. Full timeCompany Overview:Morgan Philips Singapore Pte. Ltd. is a leading medical device company dedicated to advancing healthcare through innovative solutions.Job Summary:We are seeking a Senior Regulatory Affairs Specialist to join our team in Singapore. This role will involve managing compliance programs and providing regulatory guidance on matters related to...
-
Senior Vice President, Public Affairs, JAPAC
2 weeks ago
Singapore Page Executive Full timeJoin a prestigious global leader in medical technology Work with a team of industry leaders driving innovation About Our Client Join our client, a leading company in the MedTech industry, as they seek a Senior Vice President of Public Affairs to provide strategic leadership across Japan, Greater China, and the Asia-Pacific region. This pivotal role will...
-
Regulatory Affairs Executive
1 week ago
Singapore INTEGRITY PARTNERS PTE. LTD. Full timeRoles & Responsibilities Regulatory Affairs Executive with global pharmaceutical company Great work culture Competitive RemunerationAn exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Executive to join their expanding team in Singapore. The successful incumbent will manage all local...
-
Regulatory Affairs Executive
1 week ago
Singapore INTEGRITY PARTNERS PTE. LTD. Full timeRoles & Responsibilities Regulatory Affairs Executive with global pharmaceutical company Great work culture Competitive RemunerationAn exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Executive to join their expanding team in Singapore. The successful incumbent will manage all local...
-
Project manager, regulatory affairs
3 weeks 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...
-
Senior regulatory affairs associate
3 weeks ago
Singapore PharmaCare Group Full timePharma Care Laboratories Pty Ltd is a dynamic Australian owned company, we operate and sell an impressive range of well-known and respected brands throughout pharmacy and grocery channels within Australia and overseas. Founded in 1985 on Sydney’s Northern beaches, we are dedicated to enriching people's lives through improved health and wellness. Job...
-
Associate, Regulatory Affairs
1 month 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...