Regulatory Affairs

**Job Information**:
Industry

**Health Care**

Job Type

**Full time**

Job Location

**Menara Biomed, 13, Jalan Cempaka SD 12/5, Bandar Sri Damansara, 52200 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur**

Salary Range

**MYR 4,000 - 6,999**

City

**Bandar Sri Damansara**

Country

**Malaysia**
- Identify Regulatory requirements in Stay up-to date with the Regulatory landscape in each Marketing Territory.
- Be responsible for Medical Device Establishment/Dealer License with authority.
- Oversee Pre-Market Medical Device Registration, Change Notification, Special Authorisation/ Exemptions with relevant government bodies.
- Oversee device related incidents/ complaints for medical device reporting requirements. Ensure reporting is timely.
- Fulfill necessary requirements as part of post-market surveillance.
- Oversee compliance to advertisement regulation and respective labeling requirements in each marketing territory.
- Oversee and Supervise Other Authorities Compliances with relevant authorities / government bodies such as Poisons (MOH MY, HSA SG), Flammables & Hazardous Substance (HS) (NEA SG); SIRIM/ IMDA (MY; SG); DVS/ AVS (MY; SG).
- Plan and Lead Implementation of yearly RA Audits internally.
- Support external regulatory agency audits/ Principal audits/ Supplier audits, providing regulatory input to minimize potential for findings of non-compliance.
- Support internal audits of respective subsidiaries and associated companies in South-East Asia on Regulatory matters.
- Work closely with the Conformity Assessment Body relevant to Product Risk Assessment and relevant regulatory implementation changes.
- Support of any regulatory issues relevant to Custom Import.
- Oversee & assist Pharmacists/ Qualified Personnel with Poison A License & MOH inspection related matters.

**Requirements**:

- Minimum Degree in Biomedical Science or related discipline with at least 5 years of similar experience.
- Good Leadership, People managing skills. Able to coach and train.
- Proactive, high performance, result oriented and manage projects with ethical integrity.
- Excellent written and Verbal communication skills with the ability to listen, articulate and advocate.
- Possess good negotiation and relationship building skills with Authorities, Consultants, auditors and foreign manufacturers.
- Scientific knowledge must be able to digest complex data while keeping the big picture through good analytical skills.
- Excellent organizational skills, meticulous, planning and presentation skills.
- Manage multiple projects and deadlines.
- Ability to identify compliance risks and escalate when necessary.
- Demonstrate both creative and critical thinking skills.
- Good at understanding processes/workflows, keen to innovate and improve.
- Possess working knowledge of ISO 9001 & GDPMD, ISO13485.