Fractyl Health · 1 month ago
Regulatory Affairs Specialist II
Burlington, MA
Full-time
Onsite
Mid Level
$115K/yr - $150K/yr
3+ years expFractyl Health is focused on regulatory affairs and is seeking a Regulatory Affairs Specialist II to support the company’s regulatory initiatives. The role involves preparing and submitting regulatory documents, maintaining compliance, and collaborating with cross-functional teams during product development and post-market activities.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Support the development and implementation of regulatory submission strategies
Assist with the preparation and maintenance of US regulatory submissions, including IDEs, PMAs, and associated supplements and reports
Help achieve/maintain CE Marking including MDR applications, maintaining technical documentation, and associated compliance activities
Support review of project documentation such as risk management files, test reports, and validations for regulatory completeness
Assess Engineering Change Orders (ECOs) for potential regulatory impact
Collaborate with cross-functional teams to address questions and support responses during submission reviews
Assist in drafting or updating regulatory standard operating procedures (SOPs)
Support review of promotional materials for compliance with regulatory requirements
Contribute to clinical trial activities and documentation in line with good clinical practice (GCP) standards
Support internal and external audits and other quality system activities as needed
Perform all duties in compliance with applicable regulations, policies, and procedures, including timely documentation and training completion
Bring a collaborative, solution-oriented attitude to daily work and other responsibilities as assigned
Qualification
Required
Bachelor's degree in Scientific, Engineering, Public Health, or a related field
Minimum of 3 years of direct experience in Regulatory Affairs or a related field
Strong understanding of FDA and EU regulations and guidance documents
Knowledge of Quality System requirements such as QSR, ISO 13485, GxP
Solid technical writing skills with experience preparing regulatory documentation
Project management skills and the ability to manage timelines within a team environment
Demonstrated ability to work independently and as part of a cross-functional team
Strong organizational skills with attention to detail
Excellent verbal and written communication skills
Curious, proactive, and eager to learn within a dynamic, fast-paced environment
High degree of professionalism, integrity, and commitment to quality
Preferred
RAPs Certification
Background in medical devices, biologics, or pharmaceutical industries, medical devices preferred
Experience with software-based and/or sterile medical devices desirable but not required
Experience with clinical trials desirable but not required
Benefits
Comprehensive benefits package
Company
Fractyl Health
Fractyl Health is a biotechnology company that provides curative therapies for metabolic diseases.
51-200 employees
H1B Sponsorship
Fractyl Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (1)
Funding
Current Stage
Public CompanyTotal Funding
$338.19MKey Investors
Taiwania Capital Management CorporationGoogle VenturesDeerfield
2025-09-26Post Ipo Equity· $60M
2025-08-05Post Ipo Equity· $23M
2024-02-02IPO
Leadership Team
Harith Rajagopalan
Co-Founder and CEO
Jay Caplan
Co-founder and President
Recent News
Longevity.Technology
2026-01-08
2026-01-06
Company data provided by crunchbase