Senior Regulatory Affairs Lead – Remote, Global Compliance

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

Job summary

A leading recruitment firm is seeking a Senior Regulatory Affairs Specialist to work remotely. This role involves representing the Regulatory Affairs function in project teams, leading regulatory projects, and developing strategies to support business goals. The ideal candidate will have over 7 years of experience in regulatory affairs, strong knowledge of medical device regulations, and excellent communication skills. Benefits include comprehensive insurance and a 401(k) matching plan.

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.
• Develop and submit high-quality technical documentation for approvals.

Skills

Regulatory Affairs experience

Knowledge of US and international medical device regulations

Effective communication and presentation skills

Ability to manage multiple assignments

Education

Bachelor's degree in scientific or technical discipline

Advanced degree preferred

Job description

A leading recruitment firm is seeking a Senior Regulatory Affairs Specialist to work remotely. This role involves representing the Regulatory Affairs function in project teams, leading regulatory projects, and developing strategies to support business goals. The ideal candidate will have over 7 years of experience in regulatory affairs, strong knowledge of medical device regulations, and excellent communication skills. Benefits include comprehensive insurance and a 401(k) matching plan.