Remote Regulatory Affairs Lead

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

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Regulatory Affairs Specialist - REMOTE. This role is crucial for representing the Regulatory Affairs function within project teams, effectively leading regulatory projects to align with corporate objectives. The individual will develop and implement regulatory strategies that support business goals while ensuring compliance with medical device regulations. Collaboration with international partners and internal teams is essential to evaluate marketing authorization pathways and ensure project success. This position also involves mentoring junior team members, influencing product compliance, and handling regulatory challenges in a dynamic environment.

Accountabilities

• Represent the Regulatory Affairs department in project meetings.
• Evaluate marketing authorization pathways with minimal oversight.
• Assess product and manufacturing changes for global markets.
• Review and approve key regulatory documents as a project team member.
• Directly interact with regulatory bodies professionally.
• Develop and submit high-quality technical documentation for approvals.
• Prepare management reports and proposals for process improvements.
• Participate in internal and external audits as a subject matter expert.
• Maintain up-to-date knowledge on regulatory requirements.
• Oversee task completion for junior team members.

Requirements

• Bachelor's degree in a scientific, engineering, or technical discipline.
• Minimum 7 years of relevant Regulatory Affairs experience.
• Advanced degree preferred for supplementing experience.
• Experience with Class III active implantable medical devices is a plus.
• Strong knowledge of US and international medical device regulations.
• Experience in successful submissions and strategic planning.
• Effective communication and presentation skills.
• Ability to manage multiple assignments and prioritize workload.
• Proactive approach to building functional expertise.
• Ability to work independently and collaboratively.

Benefits

• Comprehensive medical, dental, and vision insurance for employee-only coverage.
• 401(k) matching plan.
• Paid Time Off starting at 3 weeks per year.
• Competitive salary with career growth opportunities.
• Employee stock options.
• Life & AD&D and long-term disability insurance.
• Education assistance for continuous learning.
• Voluntary commuter benefits and pet insurance.
• Weekly company lunches and occasional team events.
• Opportunity to work on meaningful projects.

Why Apply Through Jobgether?

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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