Current jobs related to Regulatory Affairs Specialist - Jakarta - Boston Scientific Corporation

  • Regulatory Affairs Specialist

    5 months ago

    Jakarta, Indonesia Johnson & Johnson Full time

    Johnson & Johnson is recruiting a Regulatory Affairs Specialist based in Indonesia The Regulatory Affairs Specialist, Medical Device, Indonesia, is a member of the local Regulatory Affairs department, responsible for actively contributing to the regulatory compliance of medical devices under their responsibility. The position is responsible for providing...

  • Regulatory Scientific Affairs Specialist

    2 months ago

    Jakarta, Indonesia Nestle Operational Services Worldwide SA Full time

    **Position Snapshot** Location: Jakarta, Head Office **Position Summary** Joining Nestlé means you are joining the largest food and Beverage Company in the world. At our very core, we are a human environment - passionate people driven by the purpose of unlocking the power of food to enhance quality of life for everyone, today and for generations to...

  • Regulatory Affair

    5 months ago

    Jakarta, Indonesia PT JADE ABADI JAYA Full time

    Tugas dan Tanggungjawab Regulatory Affairs: 1. Pemahaman Peraturan dan Perundangan: Tugas utama dari Regulatory Affairs adalah memahami dan mengikuti peraturan dan perundangan yang berlaku di Indonesia. Ini melibatkan pemantauan dan pemahaman terhadap peraturan yang dikeluarkan oleh otoritas regulasi terkait. 2. Perizinan dan Registrasi: Regulatory Affairs...

  • Regulatory Affairs

    2 months ago

    Jakarta, Indonesia LeaderMed Group Full time

    Responsible for managing and submitting regulatory filing materials, communicating with government departments, and handling matters related to regulatory filing strategies. - Ensure compliance with local, national, and international regulatory requirements for company products, and develop **Corporate Regulatory Manuals & Guidelines** as company standards...

  • Regulatory Affairs Specialist

    5 months ago

    Jakarta, Indonesia PT Tentang Anak Bahagia Full time

    **About Tentang Anak** Imagine a career where you play a pivotal role in ensuring the success and bright future of 80 million children in Indonesia. Tentang Anak is not just a company; it's a mission, a movement, and an opportunity to be part of something truly extraordinary. Our products are the one and only in Indonesia that are developed by experts,...

  • Manager Regulatory Affairs

    5 months ago

    Jakarta, Indonesia DKSH Full time

    **Location**:Jakarta, ID, ID**Job Function**:Regulatory Services**Requisition Number**:137312**Description**: **Job Summary** Manage the local implementation of the company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and...

  • Regulatory Affairs Manager

    5 months ago

    Jakarta, Indonesia Artixio Consulting Pvt Ltd Full time

    10+ years of regulatory affairs experience in the pharmaceutical and medical devices industry **Prior experience preparing and reviewing submissions to BPOM** - Experience in Submission of New Drug Applications, Generic Drug Applications, Medical Devices Registration - Experience in Post Marketing Maintenance, Lifecycle Management of Marketed Drugs and...

  • Regulatory Affairs Manager

    3 weeks ago

    Jakarta, Indonesia PepsiCo Full time

    Overview: **About the job**: To strengthen our growth, we are looking for talent as Regulatory Affairs Compliance Manager **What can you expect?** Own the regulatory compliance work and regulatory work for each innovation projects for food and beverage business in Indonesia to run formula & ingredient compliance assessment, develop product labelling...

  • Supervisor Regulatory Affairs

    5 months ago

    Jakarta, Indonesia DKSH Full time

    **Location**:Jakarta, ID, ID**Job Function**:Regulatory Services**Requisition Number**:156030**Description**: **Job Summary** Supervise the execution of company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and...

  • Principal Regulatory Affairs Specialist

    1 month ago

    Jakarta, Indonesia Medtronic Full time

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life **:We are a learning culture. An inventive and collaborative group. We are dedicated to making...

  • Associate Manager, Regulatory Affairs

    5 months ago

    Jakarta, Indonesia International Flavors & Fragrances Full time

    Are you passionate about Regulatory Affairs? Would you love to work for a global organization that is doing more good for people and planet? Joining science and creativity, we are an international collective of thinkers who partner with customers to bring scents, tastes, experiences, ingredients and solutions for products the world craves. We have an...

  • Regulatory Affairs Executive

    4 months ago

    Jakarta, Indonesia Amway Inc. Full time

    Job Summary We are seeking a highly motivated and detail-oriented Regulatory Affairs Executive to join our team. In this role, you will be responsible for ensuring compliance with all relevant regulations and standards governing our industry. You will work closely with Amway’s Global Innovation & Science team and collaborate with local cross-functional...

  • Manager Regulatory Affairs

    2 weeks ago

    Jakarta, Indonesia DKSH Full time

    Location: Jakarta, ID, ID- Global Business Unit: PM- Job Function: Regulatory Services- Requisition Number: 166789- Description: **Job Summary**: Manage the local implementation of the company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and...

  • Regulatory Affairs Specialist for Indonesia

    2 months ago

    Jakarta, Indonesia Thermo Fisher Scientific Full time

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office The Regulatory Affairs and Quality Supervisor (Lead) is responsible for execution of PT Indonesia quality assurance, registration policies and standards, and ensures the regulatory compliance to local and international regulations. The role will call for a strong strategic...

  • Regulatory Affairs Officer

    5 months ago

    Jakarta, Indonesia PT. Merhati Keluarga Medika Full time

    PT. Merhati Keluarga Medika is a healthcare company that focuses in innovative pharmaceutical and medical device products. We are now seeking a _**Regulatory Affairs Officer & PJT **_as the team continues to grow and develop into its next phase. **I. Qualifications & Requirements** - At least 2 (two) years of relevant experience in regulatory affairs in a...

  • Custom & Regulatory Affairs Manager

    5 months ago

    Jakarta, Indonesia Humana International Full time

    **Responsibilities**: - ** Develop relationships with National and Local Customs, Quarantine Bureau, Air **Defense**, CAAC, SAA and other regulatory authorities.**: - ** Develop and implement a Customs & Regulatory strategy that facilitates improvements in Customs Clearance and Operational Performance, Productivity and Cost in the medium to long...

  • Customs & Regulatory Affairs Manager

    5 months ago

    Jakarta, Indonesia PT Humana International Indonesia Full time

    **Responsibilities**: - **Develop relationships with National and Local Customs, Quarantine Bureau, Air Defense, CAAC, SAA and other regulatory authorities.**: - **Develop and implement a Customs & Regulatory strategy that facilitates improvements in Customs Clearance and Operational Performance, Productivity and Cost in the medium to long term.**: -...

  • Regulatory Affairs Officer

    5 months ago

    Jakarta, Indonesia PT. Ultra Sakti Full time

    1. Pendidikan mínimal Apoteker, IPK min. 3 (Skala 4) 2. Pengalaman mínimal 2 tahun di bidang Regulatory Affairs Officer **3. Keterampilan yang harus dimiliki**: bicara & menulisa dalam bahasa Inggris, datail, komunikasi, ketelitian, dan kerjasama 4. Memiliki keinginan tinggi untuk belajar **5. Penempatan kerja**: Bekasi "Waspada terhadap Modus Penipuan...

  • Regulatory Affairs

    5 months ago

    Jakarta, Indonesia BAXTER Full time

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Regulatory Affairs Specialist

    5 months ago

    Jakarta, Indonesia MSD Full time

    **ROLES & RESPONSIBILITIES** **New Product Launching** - Actively involved in new product registration and launching, review registration dossier, monitor & performing best approach to registration process, and to provide update to cross-functional team in new product launch plan in order to ensure alignment to company strategy. - Prepare and compile...

Regulatory Affairs Specialist

5 months ago

Jakarta, Indonesia Boston Scientific Corporation Full time

**Regulatory Affairs Specialist**:

- Remote Eligible: Hybrid- Onsite Location(s): Jakarta, IDWe are seeking a Regulatory Affairs Specialist for our Indonesia Team. He/she ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation. He/she Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation and provides management team with regular updates on product registration and new regulations from government body.

**Key Responsibilities**
- Provides input on regulatory-related issues associated with compliance and achieving the business plan. Provide the management team with regular updates on product registration and/or timely escalation with proposed solution.
- Ensure product registrations are reviewed and renewed as required.
- Ensure product change/ amendment are approved in timely manner and work with relevant stakeholders to minimize business disruption
- Ensure any other compliances such as labeling requirement, SDPPI, any other reporting
- To keep abreast of local regulatory updates, guidelines and new regulations, and its implementation
- Establishes relationships with local medical device industry groups and works independently or with industry peers for advocacies to the Competent Authorities in matters of regulatory issues and to influence local policies.
- To actively liaise with regional/ global partners pertaining to regulatory affairs and providing support in the development of regulatory strategies and plans.
- Support internal audit or any external audit
- Review and obtain approval, where necessary, for Promotional Materials
- Supports any other relevant activities or as assigned

**Key Skills and Experiences**
- Prior experience of minimum 5 years in Medical Device Regulatory Affairs
- Knowledge of GDPMD will be value added
- Solid oral and written communication skills (both English and Indonesian)
- Strong analytical and critical thinking
- Team player


**Job Segment**:Regulatory Affairs, Medical Device, Compliance, Law, Internal Audit, Legal, Healthcare, Finance