Regulatory Affairs Specialist II at Fractyl Health

Burlington, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree in Scientific, Engineering, Public Health, or a related field
RAPs Certification preferred
Minimum of 3 years of direct experience in Regulatory Affairs or a related field
Background in medical devices, biologics, or pharmaceutical industries (medical devices preferred)
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
Experience with software-based and/or sterile medical devices desirable but not required
Experience with clinical trials desirable but not required
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

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

Skills

Regulatory Submissions

IDE

PMA

CE Marking

MDR

GCP

SOPs

Engineering Change Orders

Risk Management

Audits

Promotional Materials Review

Technical Documentation

Fractyl Health

Therapies for Type 2 Diabetes treatment

About Fractyl Health

Fractyl focuses on creating therapies for Type 2 Diabetes (T2D) and obesity, targeting the root causes of these metabolic diseases. Their main product, Rejuva, is a gene therapy designed to enhance the function of islet cells in the pancreas, which are essential for blood sugar regulation. By improving these cells, Fractyl aims to help patients achieve long-term remission from T2D and obesity. Currently, Rejuva is in preclinical development and has received a CE mark for commercial availability in Europe, although it is still awaiting full FDA approval. Unlike many competitors, Fractyl's approach centers on addressing the underlying mechanisms of these diseases rather than just managing symptoms. The company's goal is to transform the treatment landscape for T2D and obesity, ultimately preventing and eliminating these conditions.

Lexington, KentuckyHeadquarters

2010Year Founded

$282.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees