Director of Regulatory Affairs

A fast-growing client of X4 Life Sciences is seeking to hire a Regulatory Affairs Director to join their team! This is an exciting opportunity to work for a leading Class II company in the industry.

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The position is hybrid, based in Lowell, MA and offers a competitive salary and benefits package. With recent funding and ongoing success, the company is on an impressive growth path.

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Key responsibilities include:

• Ensuring compliance with international regulations (EU, US, Korea, Taiwan, Japan, Russia)
• Supporting regulatory activities alongside Product Development, R&D, and Manufacturing teams
• Contributing to the company’s Quality System and activities
• Managing Technical Files and Regulatory Documentation
• Leading external audits for the company

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If you’re interested in learning more about this role, please apply through the job posting.

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Feel free to share the opportunity with anyone in your network who may be a great fit—we offer a referral bonus for successfully placed candidates.