Regulatory Affairs Specialist
GE HealthcareSalary not specified
Full Time
Junior (1 to 2 years)
Regulatory Affairs Specialist II at Fractyl Health
Burlington, Massachusetts, United States
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
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What experience is required for the Regulatory Affairs Specialist II position?
A minimum of 3 years of direct experience in Regulatory Affairs or a related field is required, preferably with a background in medical devices, biologics, or pharmaceutical industries.
What education is needed for this role?
A Bachelor’s degree in Scientific, Engineering, Public Health, or a related field is required, with RAPs Certification preferred.
What key skills are essential for success in this position?
Candidates need a strong understanding of FDA and EU regulations, knowledge of Quality System requirements like QSR and ISO 13485, solid technical writing skills, and project management abilities.
Is remote work an option for this role?
This information is not specified in the job description.
What is the salary or compensation for this position?
This information is not specified in the job description.
What does the company culture emphasize for this role?
The role emphasizes a collaborative, solution-oriented attitude, working independently and as part of cross-functional teams in a dynamic environment.
What makes a strong candidate for this position?
Strong candidates will have 3+ years in Regulatory Affairs with medical device experience, regulatory knowledge, technical writing skills, and a proactive, collaborative mindset.
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