Regulatory Affairs Assistant

5 days ago

Singapore AITBIOTECH PTE. LTD. Full time

Manage document control process for Quality Management Systems in compliance with ISO13485, GDPMDS and any other standards as appropriate
- Assists in meeting the company’s objectives and sales goals by your effort in implementing smooth workflows and processes to have a highly efficient and functional sales support operation
- Develop and maintain standard operating procedures and working practices
- Prepare supporting documents for submissions to local and/or overseas health authorities for new product registration
- Responsible for regulatory and product licensing-related activities.
- Support (internal & external) audits to ensure that regulatory and quality requirements have been met
- Assist sales team in discussion with clients on regulatory matters
- Ability to manage multiple simultaneous activities in a rapidly changing environment
- Such other responsibilities as required and instructed by your superior and the management

**Job Requirement**:

- Bachelor’s degree preferably in Biotechnology, Biomedical Sciences, Life Sciences, or Biochemistry.
- Translator for chinese regulatory related document.
- Proficiency in Chinese is a must for communication with our Chinese partners.
- Fluent English; excellent written and verbal communication skills.
- Proficient in Microsoft Office
- Good interpersonal skills to 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

  • Surveillance Regulatory Affairs Officer

    1 week ago

    Singapore Marina Bay Sands Full time

    Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands 2 weeks ago Be among the first 25 applicants Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands Get AI-powered advice on this job and more exclusive features. LOVE WHAT YOU DO? THERE IS A PLACE FOR YOU HERE!Be part of our diverse and...

  • Regulatory Affairs

    2 days ago

    Singapore Search staffing services pte ltd Full time $120,000 - $150,000 per year

    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.Regulatory Affairs & QMS Manager.Reporting to the Chief QARA Officer (Based in Singapore), you will be...

  • Regulatory Affairs Specialist

    7 days ago

    Singapore Reeracoen Singapore Pte Ltd Full time

    Overview Job title: Regulatory Affairs Specialist. Reference ID: 36639. Our 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...

  • Associate, Regulatory Affairs

    3 days ago

    Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full time

    **About APACMed** Founded 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 committed to facilitating...

  • Regulatory Affairs Specialist

    3 days ago

    Singapore Ethos BeathChapman Full time

    **Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-179384 **Contact** Roselle Cuntapay **Posted** about 3 hours ago - Currently recruiting for a Regulatory Affairs Specialist for a small Medical Device business. Their product is currently in a couple of markets (and doing well) but they are...

  • Specialist, Regulatory Affairs

    1 day ago

    Singapore Resmed Full time

    Position Specialist, Regulatory Product Strategy & Delivery – Singapore (Regulatory Affairs)Overview Regulatory Affairs at ResMed is central to ensuring timely and compliant access to global markets. The Singapore RPSD team leads regulatory strategy and delivery for products where ResMed Singapore is the legal manufacturer, supporting New Product...

  • Regulatory Affairs Director

    3 days ago

    Singapore ABIORES PTE. LTD. Full time

    Develop and implement regulatory strategies to secure product approvals more quickly than competitors. - Lead complex decision-making processes among stakeholders and senior leadership in a dynamic regulatory environment. - Provide expert advice on regulatory strategy, Health Authority engagement, and submission activities for the IVD product lines. -...

  • Regulatory Affairs Specialist

    5 days ago

    Singapore Johnson & Johnson Full time

    Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of...

  • Specialist, Regulatory Affairs

    7 days ago

    Singapore ResMed (Malaysia) Sdn Bhd (MY) Full time

    About ResMed At ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and...

  • Regulatory Affairs Manager

    3 days ago

    Singapore DSM-Firmenich Full time

    COMPANY DESCRIPTION As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create...