Senior Regulatory Affairs Lead – Remote, Global Compliance

Medium; Remote; MYR 100,000 - 150,000; Full time

Job summary

A leading medical device company is seeking a Senior Regulatory Affairs Specialist to represent its department in project meetings and evaluate marketing authorization pathways. With a remote work model, this role requires at least 7 years of experience in Regulatory Affairs and a Bachelor's degree in a relevant field. Successful candidates will have a strong knowledge of US and international medical device regulations, the ability to work independently, and effective communication skills. Competitive benefits include comprehensive insurance and career growth opportunities.

Benefits

Comprehensive medical, dental, and vision insurance

401(k) matching plan

Paid Time Off starting at 3 weeks per year

Employee stock options

Education assistance for continuous learning

Qualifications

• Minimum 7 years of relevant Regulatory Affairs experience.
• Experience with Class III active implantable medical devices is a plus.
• Proactive approach to building functional expertise.

Responsibilities

• Represent the Regulatory Affairs department in project meetings.
• Evaluate marketing authorization pathways with minimal oversight.
• Review and approve key regulatory documents as a project team member.

Skills

Strong knowledge of US and international medical device regulations

Effective communication and presentation skills

Ability to manage multiple assignments

Education

Bachelor's degree in a scientific, engineering, or technical discipline

Advanced degree preferred

Job description

A leading medical device company is seeking a Senior Regulatory Affairs Specialist to represent its department in project meetings and evaluate marketing authorization pathways. With a remote work model, this role requires at least 7 years of experience in Regulatory Affairs and a Bachelor's degree in a relevant field. Successful candidates will have a strong knowledge of US and international medical device regulations, the ability to work independently, and effective communication skills. Competitive benefits include comprehensive insurance and career growth opportunities.