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 7,000 - 9,999**

City

**Bandar Sri Damansara**

Country

**Malaysia**

**Responsibilities**
- Identify Regulatory requirements in Stay up-to date with Regulatory landscape in each Marketing Territory
- Company representative, committee member in local medical device industry association, MMDA
- Consistently initiate, validate, review, plan & strategies to ensure products compliance with applicable statutory and regulatory requirements.
- Communicate Regulatory updates to relevant internal stakeholders ensuring alignment across departments
- Plan and initiate Process Improvement, digitalization of RA workflows
- 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 are 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 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**:
**Qualifications**
- Minimum Degree in science or related discipline with at least 7 years of similar experience.
- Microsoft Office (Outlook, Excel, Word, PowerPoint, etc.) Organized
- Good Leadership, People managing skills; Able to coach and train
- Possess good communication skills and ability to liaise with authorities, consultants, auditors and foreign manufacturers.
- Possess knowledge and experience in handling Medical Device Registrations/ Compliance in Malaysia, Singapore and Indonesia.
- Possess working knowledge of ISO 13485, ISO 9001 & GDPMD
- Basic bio-medical knowledge and ability to understand products (medical devices)
- Understand daily operation flow and ability to identify inefficiencies to make improvement.
- Meticulous, Able to work independently.
- Good analytical and presentation skills.
- Proactive, high performance, result oriented and manage projects with ethical integrity