Current jobs related to Medical Device Regulatory Lead - Penang - Ambu AS

  • Medical Device Regulatory Expert

    2 days ago

    Penang, Malaysia Ambu AS Full time

    Job SummaryAmbu A/S seeks an experienced Medical Device Regulatory Expert to support our global regulatory efforts.This role involves working closely with cross-functional teams to ensure regulatory compliance and quality assurance.Main Responsibilities:Regulatory IntelligenceStay up-to-date on regional regulations and guidelines applicable to medical...

  • Medical Device Specialist

    1 week ago

    Penang, Malaysia Dawn Medical Technologies Full time

    We are seeking a highly motivated Sales Specialist to join our team at Dawn Medical Technologies. As a Sales Specialist, you will play a crucial role in promoting our medical devices in the healthcare market.Responsibilities:Build strong relationships with healthcare professionals, including surgeons, clinical specialists, and gastroenterologists.Identify...

  • Senior Plastics Engineer

    1 week ago

    Penang, Malaysia Plexus Corp. Full time

    This role offers an exciting opportunity for a motivated and experienced professional to join Plexus Corp. as a Molding and Tooling Director. As a key member of our team, you will be responsible for overseeing the design, development, and production of plastic components used in medical devices.The ideal candidate will have a strong understanding of medical...

  • Medical Device Manufacturing Lead

    1 week ago

    Penang, Malaysia Plexus Corp. Full time

    We are looking for a highly skilled individual to lead our medical device manufacturing efforts as a Senior Plastics Engineer. The successful candidate will have a bachelor's degree in Mechanical Engineering, Plastics Engineering, or a related field, and at least 10 years of experience in plastic injection molding.Key responsibilities include managing a team...

  • Head of Medical Device Packaging

    2 weeks ago

    Penang, Malaysia Ambu AS Full time

    Job SummaryAmbu A/S is seeking a talented Head of Medical Device Packaging to lead our packaging development efforts.This role requires a deep understanding of medical device packaging regulatory requirements and a proven track record of developing innovative packaging solutions.Key ResponsibilitiesDevelop and implement comprehensive packaging strategies for...

  • Process Improvement Specialist Medical Devices

    5 hours ago

    Penang, Malaysia Ambu AS Full time

    We are looking for a seasoned Process Improvement Specialist to support our growing Innovation Process Team in Medical Devices. The ideal candidate will have a proven track record of identifying areas for improvement and leading initiatives to enhance efficiency, effectiveness, and compliance within the design control and process framework.The Process...

  • Medical Device Design Control Expert

    5 hours ago

    Penang, Malaysia Ambu AS Full time

    Ambu A/S is seeking a highly skilled Medical Device Design Control Expert to join our Innovation Process Team. As a key member of this team, you will play a critical role in ensuring the design control processes are compliant with regulatory requirements such as FDA and ISO.The successful candidate will have experience in creating and implementing...

  • Global Regulatory Affairs Manager

    2 days ago

    Penang, Malaysia Ambu AS Full time

    About the RoleWe are looking for a talented Global Regulatory Affairs Manager to lead our regulatory efforts in the medical device industry.This role requires expertise in regulatory affairs, quality assurance, and medical devices.Main Responsibilities:Regulatory StrategyDevelop and implement regulatory strategies to ensure compliance with regional...

  • Medical Device Packaging Development Specialist

    2 weeks ago

    Penang, Malaysia Ambu AS Full time

    About UsAmbu A/S is a leading manufacturer of single-use endoscopy, anesthesia, and patient monitoring solutions.We are seeking a talented Packaging Engineer to join our R&D team and contribute to the development of innovative packaging solutions.Job ResponsibilitiesDesign and develop product packaging by using inventor or equivalent CAD software for the new...

  • Medical Representative

    2 weeks ago

    Penang, Malaysia Rapha Medical Sdn Bhd Full time

    **Responsibilities**: - Responsible for the sales and marketing of healthcare products & medical devices - Maintain and strengthen relationship with existing customers - To generate sales leads and secure new accounts - Liaison with local and overseas distributors - Provide inputs to and execute annual marketing and training agenda **Job Requirements**: -...

  • Regulatory Affairs Specialist, Asia Pacific Region

    3 weeks ago

    Penang, Malaysia Accuray Asia Ltd Full time

    Regulatory Affairs Specialist, Asia Pacific RegionPenang, MalaysiaPosition Title: Regulatory Affairs Specialist, Asia Pacific RegionWe are seeking a Regulatory Affairs Specialist, Asia Pacific Region who will support obtaining medical device pre-market regulatory approvals to ensure market access for Accuray products and services in Asia Pacific. This...

  • Medical Device Sales Representative

    2 weeks ago

    Penang, Malaysia Johnson & Johnson Full time

    About the OpportunityWe are seeking a Sales Executive to join our team in Penang. As a Sales Executive, you will be responsible for driving sales growth and expanding our customer base.ResponsibilitiesMakes regular visits to customer locations to gather information on orders and market conditions.Performs contract and/or tender management activities.Targets...

  • Regulatory Compliance Specialist

    2 days ago

    Penang, Malaysia Ambu AS Full time

    Job DescriptionAmbu Global Hub is seeking a highly skilled Regulatory Compliance Specialist to join our Global Emerging Market (GEM) team in Penang, Malaysia.This role is responsible for ensuring regulatory compliance and quality assurance in the medical device industry.Main Responsibilities:Regulatory ComplianceCapture and coordinate information, prepare...

  • Innovation Process Team Lead

    5 hours ago

    Penang, Malaysia Ambu AS Full time

    Ambu A/S is seeking an experienced Innovation Process Team Lead to oversee the development, implementation, and maintenance of R&D design-control processes in compliance with regulatory requirements. The successful candidate will have a deep understanding of industry regulations, experience in creating and implementing procedures, and a proven ability to...

  • Quality Software Engineer for Medical Devices

    1 week ago

    Penang, Malaysia Ambu AS Full time

    We are a dynamic and fast-growing workplace with a focus on the person, not just the job. We offer a wide range of exciting job challenges, social activities, and continuous professional and personal development.We are seeking a Quality Software Engineer for Medical Devices to join our team. In this role, you will play a key part in developing and...

  • Commercial Development Representative

    1 week ago

    Penang, Malaysia Dawn Medical Technologies Full time

    Dawn Medical Technologies is a leading healthcare-dedicated investment firm that advances healthcare in emerging markets through access and affordability. We are seeking a skilled Sales Specialist to join our team in KL and Penang, among other areas.Job Requirements:Bachelor's degree in Science, Biomedical Engineering, Nursing, or a related field.At least 2...

  • Packaging Engineer Lead

    2 weeks ago

    Penang, Malaysia Ambu AS Full time

    About the RoleAmbu A/S is currently looking for a highly skilled Medical Device Packaging Development Specialist to join our R&D team.This position reports directly to the Head of R&D Packaging & Failure Analysis. The successful candidate will be responsible for leading the development of packaging solutions for new platform products and lifecycle products...

  • Medical Device Quality Leader

    4 days ago

    Penang, Malaysia Boston Scientific Gruppe Full time

    Leadership OpportunitiesWe offer a challenging and rewarding career path for Senior Quality Engineers who want to take on leadership roles. As a leader in QSR and ISO/MDD standards within your group, you will promote awareness of best industry practices and drive continuous improvement and innovation from a quality perspective.Responsibilities:Lead a team of...

  • Logistics Control and Regulatory Affairs Manager

    5 days ago

    Penang, Malaysia INTEL Full time

    Lead Intel Risk and Control incorporating overall Logistics operation areas via environmental scan and assessment from all aspects. This is inclusive risk radar, classification, and mitigation definition to reduce the risk levels. - Work closely with the Operations Management team to identify, develop, and priorities initiatives that will improve the quality...

  • Molding Manager

    3 weeks ago

    Penang, Malaysia Plexus Corp. Full time

    A Plastic Molding Engineering Manager in the medical device industry is responsible for overseeing the design, development, and production of plastic components used in medical devices. This role requires a deep understanding of medical device regulations, quality control standards, and the specific requirements of the medical industry.Key...

Medical Device Regulatory Lead

2 weeks ago

Penang, Malaysia Ambu AS Full time
Job Overview

Ambu Global Hub is seeking a seasoned Regulatory Affairs Professional to lead our Global Emerging Market (GEM) team based in Penang, Malaysia.

This role is critical in ensuring Ambu's compliance with regional regulations and standards, guaranteeing the quality and safety of our products.

Main Responsibilities
  1. Regulatory Affairs
  • Coordinate the preparation and submission of regulatory documentation to regulatory agencies or to commercial partners/distributors.
  • Oversee the timely completion of license renewals, updates, and registrations.
  • Maintain accurate regulatory files/database and chronologies. Implement a system for tracking changes in documents submitted to agencies or distributors.
  • Conduct thorough reviews of labeling and labels to ensure compliance with regulatory requirements.
  • Evaluate changes to existing products and SOPs to determine the requirements for regulatory submissions.
  • Provide regulatory reviews of customer complaints and define regulatory reportability; manage vigilance reporting communication within GEM territory specifically in Eastern Europe, Middle East & Africa (EEMEA).
  • Maintain current knowledge of applicable regional regulation, guidance, and standards applicable to company products.
Quality Assurance
  • Ensure compliance with distributor requirements within GEM territory specifically in EEMEA by establishing and maintaining Distributor Quality Agreements.
  • Note: Territory of responsibility is EEMEA, however, there may be times when the employee is asked to cover/assist other GEM colleagues with regulatory duties within their geographical areas of responsibility.
Requirements
  1. Bachelor's degree or professional qualification, preferably in Life Science, Pharmacy, Biotechnology or any related technical field.
  2. Established candidate with 5-6 years' experience in Regulatory Affairs/Medical Device industry.
  3. Quality assurance experience in the medical industry would be an advantage.
  4. Able to work independently with minimal supervision.