Regulatory Affairs Specialist Consultant - RAC-devices certification, experience with robotic systems, AI, SaMD, neuro devices

Please contact Abdul on "" OR email me at ""

Location: Hybrid preferred (near site), but open to remote anywhere in the U.S.

Work Schedule: Standard hours 8:00 AM 5:00 PM (candidate s time zone)

Travel: Up to 5%

Reason for Opening: New position due to division growth.

Team Structure:- 3 other team members; reports directly to the manager. - Works cross-functionally with multiple teams.

Top 5 Success Attributes

1. Experience writing regulatory submissions (IDE, Q submissions).

1. Collaboration with R&D and Quality for design control implementation.
2. Strategic mindset for proposing regulatory pathways.
3. Experience dialoguing with FDA.
4. Expertise in CE marking and EU MDR compliance.

Position Overview

The Regulatory Affairs Specialist Consultant will lead regulatory activities for a novel robotic medical device in the U.S. and international markets (Europe, Asia). This includes preparing and authoring regulatory submissions, managing interactions with regulatory bodies, supporting clinical affairs, and ensuring compliance with global standards.

Key Responsibilities

- Prepare and author regulatory documents (Design Dossiers, Technical Files, IDE, De Novo submissions).

- Manage regulatory submissions for U.S. and international markets.

- Interact with regulatory bodies (FDA, Notified Body).

- Support Clinical Affairs with Clinical Evaluation Reports and Post Market Surveillance.

- Define regulatory requirements for new product development and ensure adherence to Design Control SOPs.

- Review validation protocols and reports for regulatory submissions.

- Maintain knowledge of regulatory requirements and ensure compliance worldwide.

- Work on complex regulatory challenges requiring deep expertise.

Required Qualifications

Education: Bachelor s degree in science or engineering (Master s preferred).

Experience:

- Minimum 10+ years in Clinical and Regulatory Affairs with proven success in regulatory submissions and approvals.

- Expertise in ISO 13485, 21 CFR 820, EU MDR Regulation (EU) 2017/745.

- Experience with medium/high-risk devices, De Novo or PMA applications.

- Skilled in authoring/managing Technical Files and Design Dossiers.

- Familiarity with global regulatory submissions (Asia, South America).

- Project management experience (MS Project).

- FDA inspections (QSIT) and Notified Body audits experience required.

Technical Skills: MS Office Suite (Word, Excel, Outlook).

Preferred: RAC-devices certification, experience with robotic systems, AI, SaMD, neuro devices.

Soft Skills

- Professional and collaborative approach.

- Strong communication skills with empathy.

- Ability to work in a lean, fast-paced environment.

Please contact Abdul on "" OR email me at ""