Regulatory Affairs Manager, APAC (MedTech)
A listed Medical Device manufacturer specialising in life changing products is seeking for a Regulatory Affairs Manager to manage the regulatory requirements across APAC throughout the product development and product launch phases.
The Opportunity
As the Regulatory Affairs Manager you will have the responsibility to oversee the regulatory requirements of medical products for the APAC region. You will be accountable for ensuring that the business remains up to date on regulatory requirements to ensure continuous approval in the region.
What we look for:
- Demonstrate experience working in Regulatory Affairs in the healthcare space including medical devices, pharmaceuticals etc.
- Gained exposure within a regulatory role minimum 5+ years’ experience and above in medical devices (preferred)
- Familiar and has an understanding of regulations and standards relating to medical products at a regional level - APAC
- Demonstrate experience in product registrations, renewals, regulatory documentation, requirements and regulatory processes
- Track and monitor regulatory submissions working closely with commercial teams’ requirements
- Keeping up to date on regulatory changes in preventing any issues or delays
- Liaise with regulatory authorities on proposals, submissions and satisfying requests or amendments
- Ability to keep abreast of any changes to legislation, medical standards and any new requirements in the APAC region
- Developing and distributing information regarding regulatory strategy for new products and keep internal and external stakeholders and teams updated regarding the regulatory processes
- Involvement in the regulatory requirements of clinical studies for new products authorship and submissions, development registration dossiers
- Strong communication skills and the ability to train and present regulatory updates to staff and management
- Experience in drafting standard operating procedures and work instructions
What we offer:
- Opportunity within an innovative MedTech company
- Working with the latest advancements in technology
- Exciting and dynamic environment
- Competitive remuneration and benefits
- Long term and future career growth
What’s next?
We are now currently shortlisting for the Regulatory Affairs Manager – APAC profile to undertake this role. We welcome applications from people within the Medical field including medical devices, pharmaceutical, biotechnology, life-science, medical engineering, regulatory and similar backgrounds.
Please reply directly to this posting with your most updated CV, current and expected salary.
We apologise that due to the high volume of applicants we may be unable to respond to everyone. Should you not hear from us, please assume your application was unsuccessful for this time and we welcome your application again the next.
We look forward to considering your application.
Engage Group Life Science - Singapore
application@ engagegroup.com.sg
Engage Group Pte.Ltd is a licensed business under the Ministry of Manpower: (EA: 18C9316)
