Remote Senior Regulatory Affairs Lead - Med Devices

Medium; Remote; IDR 300.000.000 - 400.000.000; Full time

Job summary

A leading global firm is seeking a Senior Regulatory Affairs Specialist to work remotely, focusing on compliance with medical device regulations. The candidate will develop and implement regulatory strategies while collaborating with international partners. Responsibilities include evaluating marketing authorization pathways, mentoring junior members, and interacting with regulatory bodies. Ideal candidates have at least 7 years of experience and a Bachelor's degree in a scientific discipline, with strong knowledge of US and international regulations.

Benefits

Comprehensive medical, dental, and vision insurance

401(k) matching plan

Paid Time Off starting at 3 weeks

Education assistance for continuous learning

Employee stock options

Qualifications

• Minimum 7 years of relevant Regulatory Affairs experience.
• Experience with Class III active implantable medical devices is a plus.
• Ability to work independently and collaboratively.

Responsibilities

• Represent the Regulatory Affairs department in project meetings.
• Evaluate marketing authorization pathways with minimal oversight.
• Assess product changes for global markets.

Skills

Regulatory Affairs experience

Strong knowledge of medical device regulations

Effective communication skills

Ability to manage multiple assignments

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

A leading global firm is seeking a Senior Regulatory Affairs Specialist to work remotely, focusing on compliance with medical device regulations. The candidate will develop and implement regulatory strategies while collaborating with international partners. Responsibilities include evaluating marketing authorization pathways, mentoring junior members, and interacting with regulatory bodies. Ideal candidates have at least 7 years of experience and a Bachelor's degree in a scientific discipline, with strong knowledge of US and international regulations.