Regulatory Affairs & Quality Specialist: Job Description February 2022
We’re looking for a Regulatory Affairs & Quality Specialist to join our team in Malaysia.
As a Malaysian Regulatory Affairs and Quality Specialist, you will be required to deliver day-to-day Malaysian regulatory and GDPMD quality services to our clients. In addition, you will support and educate our clients on regional regulatory developments via meetings, webinars, papers, training.
You will have a good understanding of Malaysian Medical Device and GDPMD regulations and possess excellent customer-facing and English skills, both written and oral. In this role, you work together with Andaman Medical’s Regulatory Affairs teams across the different countries as well as our Business Development and Sales teams. Furthermore, you will actively contribute to quality management practices at Andaman Medical, including ISO13485 and GDPMD.
- Deliver Andaman regulatory services, including regulatory intelligence, product registration, and authorized representation all while maintaining regular communication with clients
- Provide clients with technical expertise, regulatory interpretation, and advice regarding MDA regulations
- Deliver quality renowned Andaman Medical services, including GDPMD certification and business license establishment
- Develop and implement valued client training, reports, and supporting materials (e.g. online regulatory updates, web-based learning, webinars, etc); and coordinate these with Andaman Medical’s Regulatory Affairs and Market Access teams across our various locations
- Assist the Sales Team in discussion with clients regarding regional regulatory matters and queries
- Monitor and analyze relevant regulatory developments by coordinating with country teams and strategizing with Business Development regarding market communication.
Professional and personal competencies
- Minimum Bachelor’s Degree or Post-Graduate Diploma in Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology
- 4+ years experience in the medical device industry, with preference given to experience in medical device regulatory affairs and Quality in GDPMD and ISO13485
- Exceptional organizational and project management skills
- Excellent communication skills (written and oral), able to translate complicated regulatory material into easily understood terminology
- Willing and able to communicate across various internal and external business functions and organizational levels (including C-level)
- Self-motivated and self-managed and able to work independently with an ownership mentality
- Team player, able to work collaboratively across various locations and cultures
- Creativity, initiative, and the ability to work effectively within a growing team are critical
- Candidates must be legally permitted to work in Malaysia.
What we offer
This is a fantastic opportunity to join our successful, highly skilled, and energized team at an exciting stage of our organizational growth! Our progressive workplace culture actively promotes modern workplace practices, professional growth, and supportive engagement opportunities with clients, partners, and internal teams.
How to apply
Send a covering letter/email and CV to email@example.com