Regulatory Affairs Specialist

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Job Description

Job Description
Description:


SerenaGroup® is a global healthcare company dedicated to developing leading comprehensive wound care solutions, conducting clinical trials, and advancing research to promote healing. We focus on advancing the science of wound healing using advanced modalities that deliver positive patient experiences and tangible, measurable outcomes. Our mission weaves together a commitment to research, scientific innovation in clinical trials, and building financially sustainable enterprises.

Role Description:


We immediately need a full-time, remote regulatory affairs specialist to join our team. In this role, you’ll own the process of preparing FDA submissions from start to finish, ensuring that everything we do meets the highest regulatory compliance standards. You’ll keep the company informed on the latest regulatory requirements, manage submissions, and serve as a resource for departments across SerenaGroup® as we grow and innovate.

What you’ll do:

  • Prepare, review, and manage regulatory submissions (especially to the FDA) from beginning to end
  • Maintain compliance with all applicable regulatory requirements and keep documentation up-to-date
  • Monitor changing regulatory landscapes and communicate key updates internally
  • Support cross-functional teams with regulatory guidance and expertise
  • Help us stay audit-ready, organized, and proactive


Requirements:

Qualifications

  • At least 3 years of hands-on experience with regulatory documentation and full-cycle FDA submissions
  • In-depth knowledge of regulatory compliance and requirements
  • Proven proficiency in regulatory affairs and related best practices
  • Outstanding attention to detail and organizational skills
  • Excellent written and verbal communication abilities
  • Comfortable working independently in a remote environment
  • Experience in the healthcare or medical device industries is a plus
  • Bachelor’s degree in health sciences, Life Sciences, Regulatory Affairs, or a related field

Our company culture is centered around our values. Our team is passionate about healing people. We embrace values that include integrity, patient first, service orientation, respect, collaboration, and maintaining a family atmosphere. If these values resonate with you, we would love you to join our team!

The salary range is $135k—$155k, depending on experience. SerenaGroup offers a competitive benefits package that includes medical/dental/vision, life insurance, short—and long-term disability, and a 401(k) with a company match.

Are you ready to raise the bar in performing clinical trials on drugs and medical devices that promote healing? Join our team and help make a difference.


Apply
Location:
Cambridge
Job Type:
FullTime
Category:
Government

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