Current jobs related to Regulatory Affairs Specialist - Singapore - ITS SCIENCE & MEDICAL PTE LTD

  • Regulatory Affairs Specialist

    3 weeks ago

    Singapore BEATHCHAPMAN (PTE. LTD.) Full time

    We are seeking an IVD product registration expert for a company specializing in the IVD space. This position will primarily focus on registering products in SEA and globally.The Regulatory Affairs Specialist will be responsible for:Reviewing current product approvals and registrations to assess the state of the SEA business.Working with the commercial team...

  • Regulatory affairs lead

    2 days ago

    Singapore HAYS SPECIALIST RECRUITMENT PTE. LTD. Full time

    Your 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...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore IQVIA Full time

    Key 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 Coordinator

    3 weeks ago

    Singapore EPIC MEDICAL PTE. LTD. Full time

    Regulatory Affairs InternshipEPIC MEDICAL PTE. LTD. is seeking a highly motivated and detail-oriented individual to join our Regulatory Affairs team as a Regulatory Affairs Intern.This exciting opportunity will provide the chance to gain hands-on experience in the preparation, submission, and monitoring of regulatory documents for healthcare/medical...

  • Regulatory Affairs Intern

    3 weeks ago

    Singapore EPIC MEDICAL PTE. LTD. Full time

    Roles & ResponsibilitiesJob Description: Regulatory Affairs InternLocation: SingaporeDepartment: Regulatory AffairsDuration: 6 monthsPosition Overview:We are seeking a highly motivated and detail-oriented intern to join our Regulatory Affairs team. As a Regulatory Affairs Intern, you will have the opportunity to gain hands-on experience in the preparation,...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore Avanos Full time

    Make a Difference with Your ExpertiseWe are looking for a talented Regulatory Affairs Specialist to join our team at Avanos. As a key member of our team, you will play a critical role in ensuring the compliance of our medical devices and products with regulatory requirements in the assigned markets.Key Responsibilities:Assist in providing regulatory input...

  • Associate, Regulatory Affairs

    4 days ago

    Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full time

    Roles & 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, Medical Devices

    2 weeks ago

    Singapore Baxter Full time

    Transforming Healthcare through Regulatory ExcellenceBaxter is deeply committed to its mission of saving and sustaining lives. As a Senior Specialist in Regulatory Affairs, you will play a critical role in ensuring our products and therapies meet the highest regulatory standards.Key Responsibilities:Develop and execute regulatory project plans with...

  • Regulatory Affairs Director

    3 weeks ago

    Singapore ABIORES PTE. LTD. Full time

    Roles & ResponsibilitiesJob Description:- 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...

  • Regulatory affairs coordinator

    1 week ago

    Singapore ResMed Inc Full time

    Regulatory 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 Director

    3 weeks ago

    Singapore ABIORES PTE. LTD. Full time

    Job Title: Senior Regulatory StrategistRegulatory Affairs at ABIORES PTE. LTD.At ABIORES PTE. LTD., we are seeking an experienced Senior Regulatory Strategist to lead our regulatory affairs efforts. As a key member of our team, you will develop and implement regulatory strategies to secure product approvals quickly and efficiently.Key Responsibilities:•...

  • Regulatory affairs coordinator

    1 week ago

    Singapore ResMed Inc Full time

    Regulatory 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...

  • Regulatory affairs specialist, sara

    4 days ago

    Singapore Mondelez International Full time

    Time left to apply: Enddatum: 30. November 2024 (Noch 17 Tage Zeit für Bewerbung) Stellenbeschreibung Make It Happen at Mondelēz International – Bist du dafür bereit? Gestalte mit uns die Zukunft des Snacking. Mach's mit Stolz. Du setzt die Regulatory Affairs-Strategie für deine Kategorie(n) und deine geographische Region mithilfe deiner...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore Baxter Full time

    Transforming Healthcare with BaxterBaxter is committed to making a positive impact on people's lives. As a Senior Regulatory Affairs Specialist, you will play a vital role in ensuring our medical devices meet the highest regulatory standards.Key Responsibilities:Develop and execute regulatory project plans to ensure timely submission of documents to...

  • Regulatory Affairs Specialist

    3 weeks ago

    Singapore SG DIAGNOSTICS PTE. LTD. Full time

    The ideal candidate for this role at SG DIAGNOSTICS PTE. LTD. will be responsible for ensuring compliance with regulatory requirements and maintaining a thorough understanding of relevant policies.Key responsibilities include:Managing regulatory plans across Singapore and APAC for new and existing products, variations, modifications, renewals and...

  • Regulatory Affairs Executive

    2 months ago

    Singapore ITS SCIENCE & MEDICAL PTE LTD Full time

    Roles & ResponsibilitiesJOB SUMMARYThe Regulatory Affairs Executive will play a critical role in ensuring that the company's products comply with all required national and international regulations and standards. This position involves working closely with various external regulatory authorities and stakeholders, and internal departments to provide expertise...

  • Regulatory Affairs Director, APAC

    2 weeks ago

    SG, SINGAPORE, VIRTUAL Solventum Full time

    Role Overview:As the Regulatory Affairs Director for Solventum, you will lead the APAC Regulatory Affairs team, playing a critical strategic role in ensuring compliance and driving business success. Your expertise will be essential in developing and executing regulatory strategies to achieve product approvals faster than competitors.Key...

  • Regulatory Affairs Manager

    2 weeks ago

    Singapore Innomar Strategies Full time

    About UsInnomar Strategies is a leading provider of healthcare solutions. We are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Coordinate and compile regulatory submissions, responses to agency questions,...

  • Regulatory affairs specialist, sara

    4 days ago

    Singapore Mondelez International Full time

    time left to apply Enddatum: 11. Dezember 2024 (Noch 28 Tage Zeit für Bewerbung) Stellenbeschreibung Make It Happen at Mondelēz International – Bist du dafür bereit? Gestalte mit uns die Zukunft des Snacking. Mach's mit Stolz. Du setzt die Regulatory Affairs-Strategie für deine Kategorie(n) und deine geographische Region mithilfe deiner...

  • Regulatory affairs manager

    2 days ago

    Singapore NYPRAX PHARMA PTE. LTD. Full time

    Position: REGULATORY AFFAIRS MANAGER (1 vacancy - immediate) Job Description (all processes will be taught in-house): Co-ordination and online submission of various formatted documentation to the Health Sciences Authority (Ministry of Health) Compiling of client's dossiers for medical devices and applications as per Ministry's requirements...

Regulatory Affairs Specialist

2 months ago

Singapore ITS SCIENCE & MEDICAL PTE LTD Full time
{"Job Summary

The Regulatory Affairs Executive will play a pivotal role in ensuring that our company's products meet all relevant national and international regulations and standards. This position involves collaborating with various external regulatory authorities and stakeholders, as well as internal departments, to provide expertise and support in regulatory affairs management.

Key Responsibilities

1. Regulatory Compliance:
  • Ensure compliance with all applicable regulatory requirements for medical devices or biotechnology products.
  • Prepare and submit regulatory documentation, including applications, reports, and amendments, to regulatory authorities such as the HSA, NEA, FDA, EMA, or other relevant bodies.
  • Maintain up-to-date knowledge of regulatory requirements and changes in global regulations.

2. Product Registration and Approval:
  • Assist in the preparation and submission of regulatory dossiers for new medical device registrations, renewals, and change notifications.
  • Liaise with regulatory agencies to facilitate the approval process and address any queries or deficiencies.
  • Liaise with regulatory representatives of various principal medical suppliers for information gathering and product regulatory updates.

3. Regulatory Strategy:
  • Develop and implement regulatory strategies for new and existing products.
  • Provide regulatory input and advice to project teams during product development to ensure regulatory compliance and timely market access.

4. Documentation and Record Keeping:
  • Maintain accurate and organized regulatory files and documentation.
  • Ensure all regulatory submissions and approvals are properly documented and archived.

5. Quality Assurance Support:
  • Collaborate with the Quality Assurance team to ensure regulatory compliance with quality control processes.
  • Participate in internal and external audits as required.

6. Cross-Functional Collaboration:
  • Work closely with internal business units to ensure regulatory requirements are integrated into new product launch and commercialization plans.
  • Provide regulatory training and guidance to internal teams as and when required.

7. Risk Management:
  • Identify and assess regulatory risks associated with product marketing and commercialization.
  • Develop risk mitigation strategies to address regulatory challenges.

8. Post-Market Surveillance:
  • Monitor and evaluate post-market safety data and adverse event reports.
  • Ensure timely reporting of adverse events to regulatory authorities as required.

Requirements

  • Bachelor's degree in life sciences, pharmacy, biomedical engineering, or a related field;
  • Minimum of 3 years of experience in regulatory affairs within the medical device, pharmaceutical, or biotechnology industry;
  • Familiarity with relevant regulatory guidelines and standards, including ISO9001, ISO13485, FDA, CE, EMA and other international regulations;
  • Strong attention to detail and organizational skills;
  • Excellent written and verbal communication skills;
  • Ability to work independently and as part of a team;
  • Strong problem-solving and analytical skills;
  • Proficiency in Microsoft Office Suite.

Additional Requirements

  • Willing to travel as required to attend regulatory meetings and conferences
  • Certification in Regulatory Affairs (e.g., RAPS RAC)

Benefits

  • Attractive remuneration package
  • Opportunities for professional development and growth
  • Modern and vibrant work environment

Tell employers what skills you have

FDA
Regulatory Compliance
Strong Attention To Detail
Ability To Work Independently
Quality Assurance
Approval Process
Regulatory Affairs
ISO
Regulatory Strategy
Risk Management
Surveillance
Medical Devices
Regulatory Requirements
Life Sciences
Regulatory Submissions
Manufacturing