Principal Regulatory Affairs Project Manager

Principal Regulatory Affairs Project Manager

Greater Philadelphia area (Hybrid, 3 days onsite) | $120K to $140K 15% bonus

About the company

This is an established global medtech and pharma/combination leader whose products are used in millions of patient treatments every day. It's financially strong and growing, and it's investing in its regulatory team as its device and combination product portfolio expands.

The role

You'll lead complex, high-visibility regulatory programs across medical devices and combination products. It's a principal-level role with a lot of autonomy, working across R&D, quality, clinical, and manufacturing, and with pharma partners and regulators.

What you'll do

• Lead global regulatory strategy and execution from early development through post-market
• Drive high-impact submissions, including 510(k)s, EU MDR technical documentation, and Master Files that support pharma partners' drug filings
• Manage regulatory risk, change assessments and responses to FDA and notified body questions
• Lead interactions with customers, partners and regulators on pre-subs, change notifications and audits
• Improve how the RA function works through better project management tools, dashboards and databases

What you'll bring

• BS in science or engineering with 5 years in regulatory affairs, or MS with 3 years
• Hands-on experience leading medical device or combination product submissions
• A track record of successful submissions and direct interaction with FDA or notified bodies
• Strong project management skills across cross-functional, matrixed teams
• Knowledge of ISO 13485, ISO 14971, 21 CFR 820 and CMC requirements

Nice to have

• RAC and/or PMP certification
• Experience supporting pharma partners' regulatory filings
• Post-market experience: change controls, CAPAs, complaints

The details

• Hybrid, 3 days a week onsite
• Up to 10% travel
• No relocation assistance