Medical Device Regulatory Specialist
3 days ago
We are seeking a highly skilled Regulatory Affairs Manager to lead our team in ensuring compliance with regulatory requirements. This role involves identifying and staying up-to-date with evolving regulatory landscapes, communicating updates to internal stakeholders, and planning process improvements.
Key Responsibilities- Regulatory Compliance: Ensure all products remain compliant with applicable statutory and regulatory requirements by initiating, validating, reviewing, planning, and strategizing.
- Communication: Communicate regulatory updates to relevant internal stakeholders to ensure alignment across departments.
- Process Improvement: Plan and drive process improvements, including the digitalization of Regulatory Affairs (RA) workflows.
- Licenses and Registrations: Oversee and maintain Medical Device Establishment/Dealer Licenses with the relevant authorities.
- Pre-Market Activities: Supervise pre-market regulatory activities including medical device registration, change notifications, and applications for special authorizations or exemptions with government bodies.
- Post-Market Obligations: Manage post-market regulatory obligations, including the reporting of device-related incidents and complaints, ensuring all submissions are timely and compliant with applicable requirements.
- Labeling and Advertising: Ensure compliance with advertisement and labeling regulations in each marketing territory.
- Education: Possess a Bachelor's Degree in Science or a related discipline, with a minimum of 7 years of relevant experience in a similar capacity.
- Technical Skills: Proficient in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
- Leadership Experience: Demonstrated track record in team leadership, preferably with experience managing a team of five or more, with strong people management capabilities including coaching and training.
- Interpersonal Skills: Excellent communication and interpersonal skills, with the ability to engage with regulatory authorities, consultants, auditors, and foreign manufacturers effectively.
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Regulatory Specialist, Medical Devices
2 weeks ago
Singapore Health Sciences Authority Full timeOverview Regulatory Specialist, Medical Devices role at Health Sciences Authority. We are looking for highly motivated individuals with a strong desire to protect public health and safety to join us as Regulatory Specialists of Medical Devices. What you will be working on Screen and evaluate medical device pre/post-marketing applications to ascertain...
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Regulatory Specialist, Medical Devices
2 weeks ago
Singapore Health Sciences Authority Full timeOverview Regulatory Specialist, Medical Devices role at Health Sciences Authority. We are looking for highly motivated individuals with a strong desire to protect public health and safety to join us as Regulatory Specialists of Medical Devices. What you will be working on Screen and evaluate medical device pre/post-marketing applications to ascertain that...
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Regulatory Specialist, Medical Devices
4 weeks ago
Singapore Health Sciences Authority Full time(What the role is)We are looking for highly motivated individuals with a strong desire to protect public health and safety to join us as Regulatory Specialists of Medical Devices.(What you will be working on)Screen and evaluate medical device pre/post-marketing applications to ascertain that medical devices meet safety, quality and performance requirements...
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Regulatory Specialist, Medical Devices
52 minutes ago
Singapore Health Sciences Authority Full time(What the role is)We are looking for highly motivated individuals with a strong desire to protect public health and safety to join us as Regulatory Specialists of Medical Devices. (What you will be working on) Screen and evaluate medical device pre/post-marketing applications to ascertain that medical devices meet safety, quality and performance...
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Regulatory Specialist, Medical Devices
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Singapore Health Sciences Authority Full time $90,000 - $120,000 per yearWhat the role is [What the role is] We are looking for highly motivated individuals with a strong desire to protect public health and safety to join us as Regulatory Specialists. What you will be working on [What you will be working on]Screen and evaluate medical device pre/post-marketing applications to ascertain that medical devices meet safety,...
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Medical Device Regulatory Expert
1 week ago
Singapore beBeeRegulatory Full time $49,120 - $63,300We are seeking a Regulatory Affairs Specialist to join our team!This role involves managing medical device registrations, ensuring compliance with regulations and providing guidance on regulatory strategy.The ideal candidate will have expertise in medical device regulatory affairs and a strong understanding of Singaporean and ASEAN regulations.
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Medical Device Regulatory Expert
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Singapore beBeeRegulatory Full timeWe are seeking a Regulatory Affairs Specialist to join our team This role involves managing medical device registrations, ensuring compliance with regulations and providing guidance on regulatory strategy. The ideal candidate will have expertise in medical device regulatory affairs and a strong understanding of Singaporean and ASEAN regulations.
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Regulatory Specialist, Medical Devices
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Medical Devices Specialist
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Singapore beBeeRegulatory Full time $90,000 - $120,000Role SummaryWe are seeking highly motivated professionals to fill the position of Medical Devices Specialist. This role involves ensuring the safety and quality of medical devices that reach the market.Main ResponsibilitiesEvaluate medical device applications to ensure compliance with regulatory requirements.Implement regulatory frameworks and communicate...
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Medical Device Specialist
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Singapore beBeeEngineering Full time $120,000 - $180,000Job Title: Medical Device SpecialistA key contributor to our organization, the Medical Device Specialist will play a pivotal role in designing, developing, and testing medical devices and equipment.Primary Responsibilities:Develop innovative medical devices and equipment, incorporating cutting-edge technologies and materialsEvaluate and analyze data from...
