Regulatory Lead(Medical Device)

2 weeks ago

Malaysia BSI Full time
Great that you're thinking about a career with BSI

Overview / Purpose of the position

  • Support the Medical Devices Notified Body and Approved Body with designation requirements;
  • Management of related local Regulated Schemes such as Malaysia GDPMD, Singapore GDPMDS, Malaysia Medical Device Regulatory Scheme and Taiwan Technical Co-Operation Programme; Build strong collaborative relationships with BSI Regulators/Accreditation Bodies to support BSI programs to include Malaysia Ministry of Health, Singapore Health Authority, Singapore Accreditation Council, and the Taiwan Food and Drug Administration; Support ISO 13485 schemes within ISO 17021, BSI, Accrediting Body, EA and IAF and other applicable accreditation requirements.
Responsibilities & Accountabilities

  • Provide regulatory input and expertise to the Operations Teams e.g. SM, TS, QMS, Commercial;
  • Own, update and provide training on Procedures in the BMS;
  • Complete reviews of external documents that impact on BSI's QMS to include Regulatory Intelligence updates;
  • Support/Deliver certification decisions and regulatory letter approvals;
  • Support the external audit process and support the closure of all nonconformities raised during audits to ensure BSI continued operation as an accredited/designated certification body and Conformity Assessment Body Status;
  • Support the development and implementation of the necessary processes and procedures to ensure continuous compliance with Medical Device Notified Body/Approved Body/Conformity Assessment Body designation / accreditation requirements;
  • Provide advice to the business in the process of developing new and revised services and products taking cognisance of the risks to the business;
  • Assist in providing general advice and guidance to all Sector, Business Stream or Regional staff on risk, legal, technical, regulatory policy and procedural issues;
  • Represent BSI in regulatory forums internally and externally
  • Asia Specific;
  • Leading and participating in process improvement projects, ensuring appropriate adherence to procedures and appropriate stakeholder involvement.

Key Success / Performance Indicators:

  • Support processes and procedures and procedures to be a fully compliant certification/notified/approved/conformity assessment body with no systematic nonconformities at audit to include local registration requirements;
  • Delivery of regulatory letters to time and quality;
  • Thorough ,prompt reporting back from meetings with third parties and effective handling of issues that arise.
  • Timely handing of projects falling within area of specialism;
  • Contribution to team performance metrics, such as document review, report review or certificate decision queue time, enquiry response time, regulation reporting timelines, training delivery effectiveness, etc;
  • Completion of project deliverables on time;
  • Adherence to both BSI technical and corporate procedures, such as cost management via appropriate expenses management;
  • Maintenance of continuing professional development and other learning/development activities.

Travel requirements:

  • Home based, can be based in Malaysia /Singapore/ Taiwan.
  • The role will involve some travel e.g. to BSI offices for team meetings, to authorities(Malaysia medical device authority, Singapore accreditation council, Singapore health authority, Taiwan FDA, International forums) and to third party locations around the globe for training, business and representative meetings(stakeholders) or audits.

Language requirements:

  • Fluent English communication skill
  • In addition, local language proficiency is advantageous.

Person Specification:

  • Thorough understanding of technical documentation required by the manufacture of medical devices including the applicable regulations and standards
  • Thorough knowledge of Medical Device QMS standards and regulation
  • A comprehensive understanding of quality systems, philosophies and principles and internal auditing principles and practices
  • An understanding of BSI, its role and its approach to certification

Skills and Abilities:

  • Conceptual and analytical thinking, efficiency and results orientation
  • A team player good at relationship building internally and externally
  • Broad technical understanding of client industry products
  • General knowledge of business principles and operating practices (commercial awareness)
  • Ability to understand and interpret legislation and input to policy.

Qualifications:

  • At lease bachelor degree in engineering, science or related discipline
  • BSI medical device competency codes for certificate decisions, document approval, competence verification.
  • Local hire only.

Personal Qualities /Aptitudes:

  • People leadership / influencing skills
  • Good interpersonal skills, particularly communication and influencing skills
  • Capable of operating with horizontal and vertical reporting lines
  • Experience of teams and projects in matrix organisations.

Our Excellence Behaviours:
Client-cen

  • Regulatory Lead(Medical Device)

    2 weeks ago

    Malaysia BSI Full time

    Great that you're thinking about a career with BSI! Overview / Purpose of the position - Support the Medical Devices Notified Body and Approved Body with designation requirements; - Management of related local Regulated Schemes such as Malaysia GDPMD, Singapore GDPMDS, Malaysia Medical Device Regulatory Scheme and Taiwan Technical Co-Operation Programme;...

  • Regulatory Affairs Specialist

    4 weeks ago

    Malaysia Monroe Consulting Group Full time

    **Regulatory Affairs Specialist**: - **Sector**: Monroe Health - **Contact**: Julia Gonsalvez - **Client**: Monroe Consulting Group - **Location**: Malaysia - **Salary**: Negotiable - **Expiry Date**: 03 November 2023 - **Job Ref**: BBBH425992_1691263303 Executive recruitment company Monroe Consulting Group Malaysia is recruiting on behalf of a leading...

  • General Manager

    2 weeks ago

    Malaysia PeopleSearch Full time

    Oversee day-to-day operations of the medical device business. - Develop and manage budgets to achieve financial targets. - Identify and pursue business opportunities, partnerships, and collaborations. - Lead and manage a cross-functional team. - Develop and execute sales and marketing strategies. - Monitor financial performance, analyze variances, and take...

  • Regulatory Affairs Specialist

    2 weeks ago

    Malaysia Monroe Consulting Group Full time

    Regulatory Affairs Specialist:- Sector: Monroe Health- Contact: Julia Gonsalvez- Client: Monroe Consulting Group- Location: Malaysia- Salary: Negotiable- Expiry Date: 03 November 2023- Job Ref: BBBH425992_ Executive recruitment company Monroe Consulting Group Malaysia is recruiting on behalf of a leading company in medical devices. Our distinguished client...

  • Manager, Regulatory Affairs

    4 weeks ago

    Malaysia fresenius medical care Full time

    Key Responsibilities / Accountabilities: Pharmacovigilance Collection of local AEs / ADRs Contact point for local regulatory authorities Forwarding of case reports and other important safety information to CDS Following up on case reports for any missing information or upon request of CDS E-mail or paper-based submission of ICSRs to authorities who...

  • Manager, Regulatory Affairs

    4 weeks ago

    Malaysia fresenius medical care Full time

    Key Responsibilities / Accountabilities: Pharmacovigilance Collection of local AEs / ADRs Contact point for local regulatory authorities Forwarding of case reports and other important safety information to CDS Following up on case reports for any missing information or upon request of CDS E-mail or paper-based submission of ICSRs to authorities...

  • Product Specialist

    2 weeks ago

    Malaysia PeopleSearch Full time

    Develop and implement strategic sales plans to achieve sales targets and expand market share. - Identify and pursue new business opportunities by prospecting, cold calling, and networking within the healthcare industry. - Build and maintain strong relationships with key decision-makers in hospitals, clinics, and other healthcare facilities. - Conduct product...

  • Medical Device Project Sales

    3 days ago

    Malaysia PeopleSearch Full time

    Develop end-to-end project sales strategies, covering everything from initial presentations to final furnishings, ensuring they meet client needs. - Drive direct sales for equipment and suggest replacements where necessary to improve project efficiency. - Expand professional networks within the healthcare industry to foster collaboration and business...

  • Medical Device Project Sales

    2 weeks ago

    Malaysia PeopleSearch Full time

    Develop end-to-end project sales strategies, covering everything from initial presentations to final furnishings, ensuring they meet client needs. Drive direct sales for equipment and suggest replacements where necessary to improve project efficiency. Expand professional networks within the healthcare industry to foster collaboration and business growth. Act...

  • Sales Coordinator

    1 week ago

    Malaysia PeopleSearch Full time

    Administrative Support: Provide administrative assistance to the sales team, including scheduling appointments, managing calendars, and organizing travel arrangements. - Event Coordination: Assist in planning and executing sales events, including coordinating logistics, managing attendee lists, and ensuring event materials are prepared. - Presentation...

  • Post Market Regulatory Affairs

    3 weeks ago

    Malaysia AlignTech Full time

    **Join a team that is changing millions of lives.** Transforming smiles, changing lives. At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have...

  • Marketing Director

    3 weeks ago

    Malaysia PeopleSearch Full time

    As the Marketing Director for Aesthetics (Medical Devices and Injectables), you will be responsible for developing and executing strategic marketing initiatives to drive the growth and market presence of our aesthetics product portfolio. This role requires a deep understanding of the medical aesthetics industry, including a strong focus on medical devices...

  • Application Specialist

    4 weeks ago

    Malaysia Michael Page Full time

    About Our Client Our client is a prominent global leading company in advanced medical and imaging solutions in Malaysia. With a solid reputation in the industry, it is recognised for its innovative technology and high-quality products to address essential healthcare challenges. The company boasts a team of dedicated professionals committed to delivering...

  • Senior Staff Engineer Device Process Control Monitoring

    2 weeks ago

    Malaysia Infineon Technologies Full time

    In this role, your main responsibilities will include: Leading a team of Process Integration engineers in improving Device Process Control Monitoring (PCM) stability and capability index (Cpk) from various technologies. Setting up and monitoring overall PCM Cpk Key Performance Index (KPI) for Management Review. Organizing and leading PCM Process Stability...

  • Senior Staff Engineer Device Process Control Monitoring

    4 weeks ago

    Malaysia Infineon Technologies Full time

    In this role, your main responsibilities will include: Leading a team of Process Integration engineers in improving Device Process Control Monitoring (PCM) stability and capability index (Cpk) from various technologies. Setting up and monitoring overall PCM Cpk Key Performance Index (KPI) for Management Review. Organizing and leading PCM Process Stability...

  • Senior Staff Engineer Device Process Control Monitoring

    4 weeks ago

    Malaysia Infineon Technologies Full time

    In your new role you will: Lead Process Integration engineers from various technologies in Device Process Control Monitoring (PCM) stability and capability index (Cpk) improvement. Set up overall PCM Cpk Key Performance Index (KPI) monitoring and responsible for regular PCM Cpk reporting for Management Review. Organize and lead overall technologies PCM...

  • Regulatory Reporting Accountant

    2 weeks ago

    Malaysia Randstad Malaysia Full time

    about the companyRandstad is partnering up with a leading UK digital bank. They are looking for a regulatory reporting accountant (UK support) to support their UK market. The role comes with replacement leave and great career progression. about the jobJob Responsibilities Ensure timely and accurate production of monthly and quarterly regulatory reports....

  • Ra Specialist

    1 week ago

    Malaysia PeopleSearch Full time

    Establishes partnerships for timely product approvals in APAC regions. - Represents regulatory affairs in project teams. - Provides regulatory guidance to cross-functional groups. - Develops APAC regulatory strategies and communicates with authorities. - Coordinates regulatory filings and certifications, stays updated on regulations, and participates in...

  • Network Lead

    2 weeks ago

    Malaysia Infinite Computer Solutions Pte Ltd Full time

    Network Lead Technical Services position is responsible for monitoring, fixing, controlling and operating network connectivity and manage related network product supported by different vendor. Be able to understand network topology, make changes for project requirement and be able to deploy project that involve in expanding into network connectivity...

  • Government Affairs and Tender Manager

    4 weeks ago

    Malaysia IQVIA Medical Full time

    Develop and maintain relationships with government officials, regulatory bodies, and relevant stakeholders. Monitor and analyze government policies, regulations, and legislative developments affecting the company. Advise internal teams on government affairs strategies to ensure compliance and mitigate risks. Lead the end-to-end tender process, including...