Regulatory Affairs Project Manager

Job Description & Skill Requirement:

The Regulatory Specialist will support end-to-end CFG and export certification activities for global markets.

Responsibilities include:

1. CFG & Export Certificate Management

• Prepare, submit, and track CFG requests via CECATS for 50 product families.

• Ensure timely renewal of CFGs expiring in 2026–27 to prevent market disruption.

• Coordinate with FDA reviewers, respond to inquiries, and ensure “first-time-right” submissions.

2. FDA Registration & Listing (R&L) Compliance

• Perform annual establishment registration & device listing updates.

• Clean up outdated product codes, obsolete SKUs, and ensure complete R&L hygiene before CFG submissions.

3. U.S. Marketing Status Verification

• Validate supporting evidence (510(k), De Novo, PMA, exemption citations).

• Coordinate with internal engineering and quality teams to confirm device status.

4. Global Market Support

• Supply CFGs and supporting technical documents to global RA teams (India, Taiwan, Indonesia, Mexico, Costa Rica, Saudi Arabia).

• Ensure country-specific wording and formatting is followed.

5. Documentation & Quality

• Prepare Letters of Authorization (LOA), declarations, and distributor support documents.

• Maintain CFG dashboards, metrics, and submission trackers.

Key Success Factors:

• Proactive queue and submission management.

• Zero‑defect, first-time-right filings.

• Strong documentation accuracy & regulatory judgement

.• Ability to support time‑critical market access renewals.

• Effective communication with FDA and global RA stakeholders.

Qualification:

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, or related field.• Minimum 3–7 years hands-on experience with FDA Registration & Listing, CECATS, CFG submissions, 510(k) clearances, and global regulatory submissions.• Strong understanding of FD&C Act, 21 CFR 807, 21 CFR 820, and export regulations.• Experience working with global RA teams, distributors, and notified bodies.

Paid Leave, Health Insurance, Group life insurance, Disability, 401(K)

The expected salary range for this position is between $63,000 to $1,20,000 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.