Stryker Poland Manufacturing sp. z o.o.Hiring

Staff Regulatory Affairs Specialist, Mako and Enabling Technologies

  • USD 95,700 to 159,500 per year
  • Remote, United States
  • Senior
  • Posted 13 days ago
Apply with Keywordise AI

or apply from Claude / ChatGPT / Muse

In one line

Remote regulatory affairs role covering robotics, navigation and imaging devices, with a preference for US Eastern time zone candidates.

About the role

The portfolio spans surgical robotics, software and capital equipment, so the job is about getting new devices and changes cleared in the US and abroad.

At a glance

Pay
USD 95,700 to 159,500 per year
Remote scope
Remote, United States
Seniority
Senior
Working hours
US Eastern time zone preferred
Skills
FDA Submissions, Medical Devices
Posted
16 Oct 2026
Last checked
29 Oct 2026

What you will do

  • Build and carry out global regulatory strategies for new products and changes.
  • Write and file FDA submissions and international registrations.
  • Check quality, preclinical and clinical documents before submission.
  • Deal with regulators and notified bodies, including written responses.
  • Review labeling and marketing claims, and coach junior regulatory staff.

What they look for

  • Bachelor's degree in engineering, science, regulatory affairs or similar.
  • At least four years in an FDA-regulated industry.
  • At least three years in regulatory affairs.
  • Experience preparing submissions for product approvals.

Nice to have

  • Regulatory Affairs Certification or a master's in regulatory affairs.

How Keywordise applies for you

  1. 1Upload your CVAdd your CV once. It takes about a minute.
  2. 2Tailored to this jobKeywordise writes a CV and a cover letter for this job from your real experience.
  3. 3The form fills itselfName, email, experience and screening questions, field by field.
  4. 4Application sentYou get a receipt and follow it in your dashboard.

Apply with Keywordise AI7-day free trial, no card.

Apply from your AI assistant

Connect Keywordise to your assistant once, then send it the prompt. It applies for you.

ClaudeConnectorChatGPTConnectorMuseby Meta

Claude

  1. In Claude, open Settings, then Connectors, and choose Add custom connector.
  2. Name it Keywordise and paste the connector URL.
  3. Click Connect, log in to Keywordise and approve. Then send the prompt in a new chat.
Connector URL
https://keywordise.com/mcp

Disconnect any time in your Keywordise settings.

ChatGPT

  1. In ChatGPT, open Settings, then Connectors. On plans that need it, turn on developer mode first.
  2. Add a new connector with the connector URL and choose OAuth. Leave the client ID and secret empty.
  3. Log in to Keywordise and approve. Then send the prompt in a new chat.
Connector URL
https://keywordise.com/mcp

Disconnect any time in your Keywordise settings.

Muse

  1. Open Muse (muse.ai or the app) and send it the message below.
  2. If Muse asks how to sign in, answer OAuth. Open the sign-in link it sends, log in to Keywordise and approve.
  3. Send the prompt. Muse asks before it sends anything.
Message for Muse
Add a custom connector called Keywordise. It is a remote MCP server at https://keywordise.com/mcp and uses OAuth. Give me the sign-in link.

Muse is available in the US only for now.

Prompt
Apply to Keywordise job iggjxz7jyo
How to connect

Questions about this job

Is this a remote job, and where can I work from?

Yes. The posting lists Staff Regulatory Affairs Specialist, Mako and Enabling Technologies as a remote role for candidates in the United States. On hours, the posting says: US Eastern time zone preferred.

What does this job pay?

The posting states USD 95,700 to 159,500 per year.

What experience is needed?

It is a senior role. The posting asks for: bachelor's degree in engineering, science, regulatory affairs or similar; at least four years in an FDA-regulated industry; at least three years in regulatory affairs. Skills it names include FDA Submissions, Medical Devices.

How do I apply with Keywordise AI?

Click Apply with Keywordise AI, create an account and upload your CV. Your CV and cover letter are written for this job from what you have really done, then Keywordise applies for you. Trial: 7 days, no card.

More remote science and research jobs

All remote science and research jobs
Stryker Poland Manufacturing sp. z o.o.Remote, United States
Apply with Keywordise AI