Regulatory Affairs Specialist II

Fractyl•Burlington, MA

31d

About The Position

The Regulatory Affairs Specialist II supports the company's regulatory initiatives to meet strategic short- and long-term objectives. This includes assisting with the preparation and submission of regulatory documents, maintaining compliance with applicable regulations, and supporting cross-functional teams during product development and post-market activities. The Specialist works closely with the Principal Regulatory Affairs Specialist and other team members to ensure regulatory requirements are met in a timely and compliant manner.

Requirements

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.
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.
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.

Nice To Haves

RAPs Certification preferred.
Experience with software-based and/or sterile medical devices desirable but not required.
Experience with clinical trials desirable but not required.

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.