Principal Regulatory Affairs Specialist

3 days 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 sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare.

**Responsibilities may include the following and other duties may be assigned**:

- Preparing and submitting regulatory submission documents and evaluate the risk of proposed regulatory strategies and offer solutions, as applicable
- Ability to comprehend orthopaedic technical terminology or can reference literature for understanding
- Directs interaction with regulatory agencies as needed, including pre and post submission discussions and negotiations, to ensure timely product approval
- Advise internal stakeholders regarding current/pending guidance, regulations to ensure regulatory strategy is in alignment with company objectives and ensures standard and process compliance.
- Works collaboratively with regulatory and cross functional business partners to achieve and maintain compliance with regulatory requirements
- Localized Advocacy to new/upcoming regulation and in partnership with APACMed (Asia Pacific Medical Technology Association), Local Association and Indonesia RA (Regulatory Affairs) Forum.

**Required Knowledge and Experience**:
**Must Have**:

- Bachelor’s degree in Pharmaceutical
- Minimum of 6-8 years’ experience in Regulatory Affairs within the medical device or healthcare industries

**Your Profile**:

- Excellent knowledge and experience with medical device and regulatory requirements
- Ability to maintain responsibility for process or key area of Regulatory
- Excellent research and analytical skills
- High sense of urgency and commitment to execution
- Experience of managing complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization

**Physical Job Requirements**

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

**Benefits & Compensation**:
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

**About Medtronic **:**We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.**
**Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.**
**We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

  • Regulatory Affairs Specialist

    3 days 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...

  • Senior Regulatory Affairs Specialist

    4 days ago

    Jakarta, Indonesia Boston Scientific Corporation Full time

    **Senior Regulatory Affairs Specialist**: - Remote Eligible: Hybrid- Onsite Location(s): Jakarta, IDWe are seeking a Senior 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...

  • Asia Pacific Regulatory Affairs Specialist

    3 hours ago

    Jakarta, Jakarta, Indonesia Xiaomi Full time

    Regulatory Affairs SpecialistXiaomi is seeking a highly skilled Regulatory Affairs Specialist to join its Asia Pacific team. In this role, you will be responsible for identifying and mitigating risks associated with regulatory requirements in the region.The successful candidate will have a deep understanding of regulatory frameworks and be able to analyze...

  • Sr. Specialist, Scientific Affairs

    3 days ago

    Jakarta, Indonesia Mondelēz International Full time

    **Job Description**: **Are You Ready to Make It Happen at Mondelēz International?** **Join our Mission to Lead the Future of Snacking. Make It With Pride.** You execute the scientific and regulatory affairs strategy for your respective category or categories and geographical area using your scientific and regulatory expertise and are responsible for the...

  • Regulatory Scientific Affairs Specialist

    6 days 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

    3 weeks 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 Director

    5 days ago

    Jakarta, Jakarta, Indonesia PT. Prima Bersama Berkat Full time

    About the RoleWe are seeking an exceptional Financial Compliance Specialist to lead our compliance efforts in Jakarta Utara. The ideal candidate will have extensive experience in managing regulatory affairs and corporate litigation, with a strong background in finance and law.Key ResponsibilitiesImplement Compliance Programs: Develop and execute...

  • Head of Regulatory Affairs

    7 days ago

    Jakarta, Indonesia Setara Networks Full time

    We at Indepay | Setara Networks are here to revolutionize the Indonesian payment ecosystem by introducing one click checkout services in order to make transactions zero-fee, instant, and rewarding for the consumer. On one side we’re working with financial institutes to enable real-time account to account transfers through our platform, and on the...

  • Regulatory Affairs Specialist

    3 days 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,...

  • Supervisor Regulatory Affairs

    4 days 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...

  • Regulatory Affair

    3 days ago

    Jakarta, Indonesia PERSOLKELLY Indonesia Full time

    Bachelor's Degree in Pharmacy and good English command - 2+ years experience as Regulatory Affairs dealing with product registration and renewal for food, nutritional supplement, and traditional medicine in Indonesia - Has relationship with government regulatory bodies (BPOM and MoH) PERSOLKELLY Indonesia is currently assisting one of multinational Retail...

  • Senior Regulatory Affairs Specialist

    5 days ago

    Jakarta, Indonesia Alterra Indonesia Full time

    Provide consultative support to product team on the methods, practices and solutions that achieve the requirements defined by applicable compliance requirements Support the development and implementation of regulation awareness training and continuous compliance improvement efforts Provide regulatory compliance advice and support to all businesses and...

  • Public and Regulatory Affairs Manager

    6 days ago

    Jakarta, Indonesia Heineken Full time

    **Job Purpose** Our Corporate Affairs ambition is to grow the business, promote the company, our brands and products and improve the business climate. In close collaboration with Corporate Affairs Director, Corporate Communications Manager and Sustainability Manager, a Public and Regulatory Affairs Manager is expected to deliver the ambition by: - Leading...

  • Regulatory Affair

    3 days ago

    Jakarta, Indonesia PERSOLKELLY Indonesia Full time

    **Location**: - Jakarta- Jakarta**Work Type**: - Full Time- Bachelor's Degree in Pharmacy and good English command - 2+ years experience as Regulatory Affairs dealing with product registration and renewal for food, nutritional supplement, and traditional medicine in Indonesia - Has relationship with government regulatory bodies (BPOM and MoH) - PERSOLKELLY...

  • Regulatory Affairs Associate

    5 days ago

    Jakarta, Indonesia Pfizer Full time

    **Why Patients Need You**:We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate...

  • Regulatory Affairs Manager

    2 weeks ago

    Jakarta, Indonesia LUXASIA Full time

    LUXASIA is the leading beauty omnichannel distribution platform of Asia Pacific that has successfully enabled brand growth for more than 120 luxury beauty brands. Our integrated brand-building capabilities include luxury retail, online commerce, consumer marketing, and supply chain management. Since 1986, the company has partnered the world’s finest...

  • Manager Regulatory Affairs

    1 week 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...

  • Senior Analyst Scientific

    5 days ago

    Jakarta, Indonesia PT. Ingredion Indonesia Full time

    **Location : Jakarta, Indonesia** **Reports to **:Head, Scientific & Regulatory Affairs, APAC** **Workplace type **:Hybrid** The **Senior Regulatory Affairs Analyst, Global Scientific & Regulatory Affairs, APAC** is responsible for conducting regulatory assessments to enable and support the growth of the Ingredion portfolio. They should have experiences...

  • Custom & Regulatory Affairs Manager

    5 days 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...

  • Head of Regulatory Affairs

    4 days ago

    Jakarta, Jakarta, Indonesia Cermati Full time

    About the CompanyCermati Fintech Group is a leading fintech company that aims to provide innovative financial solutions to its customers. We are currently seeking a Head of Regulatory Affairs to join our team and help us navigate the complex regulatory landscape of the fintech industry.The successful candidate will have minimum bachelor's degree in Law,...