Senior Regulatory Affairs Specialist, APAC

2 weeks ago

Singapur, Singapore Boston Scientific Full time

 

Additional Locations: Australia-NSW-Mascot; China-Shanghai; Japan-Tokyo

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

 

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

Purpose Statement

The purpose of this role is to provide regulatory expertise and leadership for APAC Sourced Finished Medical Devices (SFMD) projects and integrations of acquired companies, ensuring alignment with business objectives and compliance with relevant regulations. The role involves developing and implementing regulatory strategies, researching and monitoring regulatory requirements, collaborating with internal and external stakeholders, and managing sustaining activities for APAC SFMD products across the region

 

Roles & Responsibilities

  • Acts as a core member on APAC SFMD project teams and Integration teams, providing Regulatory Affairs guidance throughout the projects
  • Collaborate with teams to guide the regulatory requirements and expectations for compliant submissions and approvals, including planning, technical background, and issue identification that may impact goals and timelines for SFMD and Integration projects
  • Develops and implements regulatory strategies for new APAC SFMD products and integrations
  • Research regulatory requirements for geographies across the region. Monitor emerging trends and integrate new requirements into projects and regional toolkits
  • Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for projects
  • Manage sustaining activities associated with APAC SFMD – including change assessments on SFMD product and manufacturing changes and distribution controls to ensure compliance with applicable regulations
  • Acts as APAC RA representative, developing and maintaining positive relationships with APAC OEM third party suppliers
  • Establish and maintain systems, processes and tools for the management of SFMD projects and Integrations across APAC. Continuously assess ways to improve

 

Requirements

  • A minimum of 5 years’ experience in the medical device industry within a regulatory affairs role
  • Working knowledge of international regulations for medical devices
  • General understanding of product development process and design control
  • Ability to manage several projects of varying scope and complexity simultaneously while adhering to time schedules
  • Effective research, analytical, and problem-solving skills
  • Excellent written and oral communication and technical writing skills. Ability to translate technical information into a clear message
  • Quick learner, self-motivated, and independent worker with minimal supervision
  • Ability to establish wide range of business relationships
  • Team player with excellent interpersonal skills

 

Requisition ID: 590170

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you

  • Regulatory Affairs Specialist, APAC

    5 days ago

    Singapur, Singapore Boston Scientific Full time

    About the RoleThe Senior Regulatory Affairs Specialist, APAC will provide regulatory expertise and leadership for APAC Sourced Finished Medical Devices (SFMD) projects and integrations of acquired companies, ensuring alignment with business objectives and compliance with relevant regulations.Key ResponsibilitiesActs as a core member on APAC SFMD project...

  • Regulatory Affairs Senior Specialist

    5 days ago

    Singapur, Singapore Baxter Full time

    Exciting Role in Regulatory Affairs at a Leading Medical Devices CompanyAre you dedicated to enhancing global healthcare? At Baxter, we are committed to saving and sustaining lives through our innovative medical products and therapies. As a Senior Specialist in Regulatory Affairs, you will be instrumental in ensuring adherence to international regulations...

  • Regulatory Affairs Senior Specialist

    5 days ago

    Singapur, Singapore Baxter Full time

    Opportunity in Regulatory Affairs at a Leading Medical Devices CompanyAre you dedicated to enhancing global healthcare? At Baxter, we are committed to saving and sustaining lives through our innovative medical products and therapies. As a Senior Specialist in Regulatory Affairs, you will be instrumental in ensuring adherence to international regulations and...

  • Regulatory Affairs Senior Specialist

    5 days ago

    Singapur, Singapore Baxter Full time

    Exciting Career Opportunity in Regulatory Affairs at a Premier Medical Devices OrganizationAre you dedicated to enhancing global healthcare outcomes? At Baxter, we are committed to saving and sustaining lives through our innovative medical products and therapies. As a Senior Specialist in Regulatory Affairs, you will be instrumental in ensuring adherence to...

  • Senior Regulatory Affairs Specialist

    5 days ago

    Singapur, Singapore Boston Scientific Full time

    About the RoleBoston Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring the timely and efficient approval of our medical device products.Key ResponsibilitiesProvide input on regulatory-related issues associated with compliance and...

  • Regulatory Affairs Specialist

    5 days ago

    Singapur, Singapore Boston Scientific Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Boston Scientific. As a key member of our regulatory team, you will be responsible for ensuring the timely and efficient approval of our medical device products.Key ResponsibilitiesProvide regulatory expertise to support the development and implementation of our...

  • Regulatory Affairs Specialist

    50 minutes ago

    Singapur, Singapore Baxter Full time

    About the RoleBaxter is a leading medical innovation company that transforms healthcare. We are seeking a highly skilled Regulatory Affairs Specialist to join our team.Key ResponsibilitiesDevelop and execute regulatory project plans with directionIdentify and elevate key areas of regulatory riskMaintain current knowledge of international regulatory...

  • Associate Director Regulatory Affairs – APAC

    3 months ago

    Singapur, Singapore Abbott Full time

    The Opportunity This Associate Director Regulatory Affairs – APAC will work on-site at our Alameda, CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business issues to enable products that are developed,...

  • Regulatory Affairs Professional

    5 days ago

    Singapur, Singapore Boston Scientific Full time

    About the RoleBoston Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring the timely and successful approval of our medical devices in the market.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance with local...

  • Associate Director Regulatory Affairs – APAC

    3 weeks ago

    Singapur, Singapore Abbott Full time

    The Opportunity As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory...

  • Regulatory Affairs Specialist

    50 minutes ago

    Singapur, Singapore Procter & Gamble Full time

    About the RoleThis is an exciting opportunity to join a highly motivated team at Procter & Gamble, responsible for ensuring the safety and regulatory compliance of our products. As a Regulatory Affairs Specialist, you will play a critical role in managing uncertainties and enabling business in complex and challenging regulatory environments.Key...

  • Senior / Regulatory Affairs Specialist

    3 months ago

    Singapur, Singapore Boston Scientific Full time

    Summary Ensures rapid and timely approvals for respective product line by plans on all product registrations, manage all product registrations' preparation and documentation.  Interacts with regulatory agencies’ personnel in order to expedite approval of pending registration and answers any questions on product documentation.  Provide management team...

  • Regulatory Affairs Specialist

    3 months ago

    Singapur, Singapore Boston Scientific Full time

    Summary Ensures rapid and timely approvals for respective product line by plans on all product registrations, manage all product registrations' preparation and documentation. Interacts with regulatory agencies’ personnel in order to expedite approval of pending registration and answers any questions on product documentation. Provide management team...

  • Senior Specialist in Regulatory Affairs

    5 days ago

    Singapur, Singapore Careers@Gov Full time

    Position OverviewThe Health Products Regulation Group (HPRG) at Careers@Gov is dedicated to ensuring that pharmaceuticals, cutting-edge therapies, medical devices, and health-related products are effectively regulated to meet essential safety, quality, and efficacy standards. HPRG plays a pivotal role in advancing biomedical sciences by implementing a robust...

  • Regulatory Relations Specialist, APAC

    2 days ago

    Singapur, Singapore Scotiabank Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Regulatory Relations Specialist to join our team in APAC. As a key member of our Global Regulatory Relations team, you will play a critical role in supporting the Head of Global Regulatory Relations and Technology Compliance, APAC in delivering the compliance program for the GBM&T businesses...

  • Senior Regulatory Affairs Specialist

    3 months ago

    Singapur, Singapore 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...

  • Senior Regulatory Affairs Associate

    2 weeks ago

    Singapur, Singapore BeiGene Full time

    Job Description: About the Position The Senior Regulatory Affairs Associate / Regulatory Affairs Manager is responsible for ensuring the regulatory compliance of therapeutic products in Singapore and other South East Asia (SEA) developing and executing regulatory strategic plans and supporting product registration and managing product life cycle...

  • Senior Regulatory Affairs Specialist

    5 days ago

    Singapur, Singapore Careers@Gov Full time

    Job Overview The Health Products Regulation Group (HPRG) at HSA is dedicated to ensuring that health-related products, including pharmaceuticals, innovative therapies, and medical devices, are regulated with utmost diligence to meet safety, quality, and efficacy standards. HPRG plays a pivotal role in advancing biomedical sciences in Singapore by...

  • Senior Specialist, Regulatory Affairs

    3 months ago

    Singapur, Singapore 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...

  • Diplomatic Affairs Specialist

    5 days ago

    Singapur, Singapore Ministry of Foreign Affairs Full time

    Job DescriptionJob Title: Foreign Service OfficerJob Summary:We are seeking a highly skilled and experienced Foreign Service Officer to join our team at the Ministry of Foreign Affairs. As a key member of our diplomatic corps, you will be responsible for analyzing and providing policy advice on geopolitical developments related to Singapore's strategic...