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 non-conformities 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 non-conformities 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

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