- Pay
- $82–106k
- Where
- San Francisco, California, GB · GB
- Level
- Mid
Make your mark as a Regulatory Submissions Manager in the Healthcare sector, based in San Francisco.
Healthcare startups move fast, but regulatory bodies don't bend their timelines for anyone.
This is a growing healthcare company building products that need to clear FDA and international submission pathways correctly, first time.
The Regulatory Submissions Manager sits at the point where scientific detail meets commercial pressure, and gets both right.
Here's what you'll be doing: Prepare and submit regulatory filings to the FDA and other relevant bodies, managing the full lifecycle from drafting through to approval Build and maintain submission timelines, flagging risks to leadership before they become problems Review technical and clinical documentation for regulatory accuracy ahead of filing Liaise directly with regulatory agencies, responding to queries and information requests Keep the team current on shifting regulatory requirements across the markets this company operates in Work closely with product, clinical and quality teams to make sure submissions reflect what's actually been built Here are the skills you'll need: Several years' experience managing regulatory submissions within healthcare, biotech or medical devices Solid working knowledge of FDA submission pathways and documentation standards Sharp attention to detail.
A missed reference or inconsistent dataset can set a submission back months The ability to explain regulatory requirements clearly to people who aren't regulatory specialists Comfort working with ambiguity and shifting priorities, common in an early-stage company Strong project management instincts, because you'll likely be running several submissions at once Key perks and benefits: $82,000 to $106,000, depending on experience Equity in the company you're helping build Hybrid working, split between the San Francisco office and home Flexible hours that fit how you actually work best A dedicated budget for learning and professional development Why pursue a career in Healthcare?
Healthcare is one of the few sectors where regulatory expertise directly shapes whether a product reaches the people who need it.
San Francisco remains one of the strongest hubs in the world for healthcare innovation, with biotech, medtech and digital health companies clustered across the city and the wider Bay Area.
For a Regulatory Submissions Manager, that density means constant exposure to new problems, and a career that keeps compounding rather than flattening out.
This Regulatory Submissions Manager opportunity is brought to you by The Opportunity Hub UK.