Global Regulatory Affairs Specialist

3 days ago

Singapore beBeeRegulatory Full time

**Job Overview**

  • Regulatory affairs specialists are responsible for ensuring compliance with global regulatory requirements.

**Key Responsibilities**

  • Develop and manage regulatory submission timelines for new and existing products across key markets.
  • Prepare and file global medical device applications and amendments to ensure timely market access.
  • Collaborate with regulatory authorities and distribution partners to support product registrations.
  • Author and maintain EU MDR-compliant technical documentation, including notifications of change.
  • Conduct global regulatory impact assessments for product and manufacturing changes through the document control process.
  • Act as the regulatory representative on cross-functional teams to integrate regulatory requirements throughout the product lifecycle.
  • Interpret and apply international regulations, standards, and directives to ensure ongoing global compliance.
  • Review and approve product labeling to ensure compliance with global regulatory requirements.
  • Support and participate in inspections and audits conducted by global regulatory authorities.

**Requirements**

  • Minimum 5 years of experience in regulatory affairs.
  • Fluent English language skills.

**Benefits**

This role offers a unique opportunity to work in a dynamic environment and contribute to the success of our organization.

**Others**

We are committed to providing a safe and inclusive workplace culture.

  • Regulatory Affairs Specialist

    1 day 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...

  • Global Regulatory Affairs Professional

    40 minutes ago

    Singapore beBeeRegulatory Full time $90,000 - $120,000

    Job Title: Global Regulatory Affairs SpecialistWe are seeking a highly skilled Global Regulatory Affairs Specialist to join our team. This role will be responsible for efficiently obtaining and maintaining product registrations in APAC countries, working closely with distributors, consultants, regulators, and HOYA affiliates.This position requires...

  • Regulatory Affairs Specialist

    2 days ago

    Singapore Johnson & Johnson Full time

    The Regulatory Affairs Specialist (MD) is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility. - The Regulatory Affairs Specialist (MD) will be a member of the local regulatory affairs department within Johnson...

  • Global Regulatory Affairs Specialist

    3 days ago

    Singapore beBeeRegulatory Full time

    Regulatory Affairs Professional\This role is responsible for managing all domestic and regional regulatory affairs, including but not limited to new drug applications (NDAs), variations, and registration renewals in Singapore and Asian countries. \\[This professional will also be responsible for establishing pharmacovigilance systems for the company's...

  • Regulatory Affairs Specialist

    2 weeks 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...

  • Regulatory Affairs Specialist

    4 days ago

    Singapore ALCOTECH PTE. LTD. Full time

    Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...

  • Pharmacist - Regulatory Affairs Specialist

    14 hours ago

    Singapore beBeeRegulatory Part time $32,000 - $40,000

    Regulatory Affairs SpecialistWe are seeking a licensed pharmacist to join us in a part-time, project-based role as a Regulatory Affairs Specialist. This position is ideal for pharmacists looking for flexible work arrangements while contributing their expertise in regulatory affairs.

  • Regulatory Affairs Specialist

    4 days ago

    Singapore ALCOTECH PTE. LTD. Full time

    Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...

  • Regulatory Affairs Specialist

    11 hours ago

    Singapore ALCOTECH PTE. LTD. Full time

    Roles & ResponsibilitiesAlcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.Role OverviewWe are seeking a Regulatory Affairs Specialist with either experience working at...

  • Regulatory Affairs Specialist

    23 hours ago

    Singapore ALCOTECH PTE. LTD. Full time

    Roles & ResponsibilitiesAlcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.Role OverviewWe are seeking a Regulatory Affairs Specialist with either experience working at...