Regulatory Affairs

7 days ago

Singapore SCIMED (ASIA) PTE LTD Full time

**ROLES & RESPONSIBILITIES
**1. Regulatory Affairs**
- Understand relevant regulatory regulations, policies & procedures behind the company’s business activities and products
- Ensure product and company’s compliance with regulations for maintenance of approvals
- Maintain ISO and GDPMDS records, and work closely with the ISO/GDPMDS team to provide timely updates on company’s regulatory and licensing matters
- Advise management on regulatory processes, compliance and updates to policies
- Responsible for the maintenance of regulatory documentation databases
- Develop and maintain communication with regulatory agencies regarding submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions and reviews
- Main contact point for various regulatory-related internal inquiries regarding logistics, pre/post-marketing events in addressing customers’ requirements.
- Support the country managers in medical device regulations or other regulations for regional countries
- Liaise with related departments in the PHC Group

**2. Quality Management System**
- Support the Management Representative in the company quality management system
- Prepare for internal and external audits and ensure successful outcomes, tackle audit findings and recommendations in a timely manner
- Follow-up and verify corrective/preventive action (CAPA) effectiveness.

**3. Compliance**
- Support the Compliance Manager in implementing PHC’s compliance program and policies
- Coordinate, schedule and conduct required compliance orientation and training for employees
- Responsible to ensure compliance to regulations related to export controls
- Manage the contracts database and business licenses, including reviewing contracts and liaising with the PHC Group legal team.

**REQUIREMENTS**
- A Degree in Life Sciences, Biomedical or any other related discipline.
- Minimum 2 years’ experience in performing a similar job scope.
- Relevant experience in regulatory affairs will be advantageous
- Able to work under a matrix reporting structure.
- Good organizational and time management skills.
- A strong database experience (Access, Excel) to set up functions, enter data or process information.
- Excellent interpersonal, presentation and verbal/written communications skills.
- Meticulous, able to work independently and timely in meeting deadlines.
- Integrity with a history of ethical decision-making is essential
- Sound knowledge of the regulatory requirements and legal framework for products and industry trends in the Asian Region.
- Knowledge in GDPMD, ISO9001, IVDR preferred.
- Familiarity with Health Science Authority’s regulatory on medical devices, product registration, field safety correction and licensing requirements.

  • Regulatory Affairs Associate

    7 days ago

    Singapore PRESTIGE BIOPHARMA LIMITED Full time

    **Job Description & Requirements** Reporting to the Regulatory Affairs Manager, you will be responsible for assisting in Regulatory Affairs activities for clinical trials and marketing authorisation. **Responsibilities** - Support regulatory assessment of submission requirements based on relevant regulations - Assist with administrative work necessary to...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Regulatory Affairs Specialist to join our Regulatory Affairs team located in Singapore. : The Regulatory Affairs Specialist is a member of the Local Operating Company (LOC) Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life...

  • 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 Intern

    2 weeks ago

    Singapore GE HEALTHCARE Full time

    **Job Description Summary**: We are seeking a detail-oriented and motivated intern to support the Regulatory Affairs team with UDI (Unique Device Identification) data entry activities for Australia and Singapore. This role is ideal for students or recent graduates interested in regulatory affairs, data management, or the medical device industry. **Key...

  • Regulatory Affairs Manager

    7 days ago

    Singapore Align Technology Full time

    **Description**: **Join a team that is changing millions of lives.** Transforming smiles. Transforming lives. Transforming an industry. At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the...

  • Regulatory Affairs Director

    2 weeks ago

    Singapore NOVO NORDISK PHARMA (SINGAPORE) PTE LTD Full time

    **About the department** You will join our Regulatory Affairs team in Region APAC, based in Singapore. Our team is responsible for ensuring regulatory compliance for new products and product amendments, thereby keeping our license to operate. We work closely with health authorities and policymakers to shape future regulatory frameworks and ensure the safety...

  • Regulatory Affairs Officer

    5 days ago

    Singapore SRS Life Sciences Pte. Ltd Full time

    **Role & Responsibility**: - The role of Regulatory Affairs Officer focuses on coordinating and documenting regulatory processes, such as inspections, license renewals, or registrations; compiling and preparing materials for submission to regulatory agencies related to regulatory initiatives; - Maintaining regulatory compliance of products for the following...

  • Director Regulatory Affairs

    2 days ago

    Singapore Planet Pharma Full time

    Director of Regulatory Affairs We’re partnering with a leading global clinical research organization (CRO) seeking an experienced Director of Regulatory Affairs to lead regional regulatory strategy and execution across APAC. This position offers the opportunity to represent the company’s regulatory strategy meetings, and Health Authority interactions –...

  • Regulatory Affairs Associate Manager

    2 weeks ago

    Singapore Johnson & Johnson Full time

    At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for...

  • Regulatory Affairs Director

    2 weeks ago

    Singapore Solventum Full time

    **3M Health Care is now Solventum** At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the...