TITLE: Regulatory Affairs Specialist

APPLY FOR THIS POSITION: on the career section of our website, www.ConforMIS.com

ConforMIS, Inc. is a privately held medical device company based in Massachusetts. It was founded in 2004 to provide dramatic advancements in patient care by utilizing imaging technology to create personalized, patient-specific implants and instrumentation. ConforMIS transforms traditional CT and MR data into patient-specific implants and instrumentation employing two related ‘image-to-implant’ technology platforms:

ConforMIS is an Equal Opportunity Employer

Job Summary:

This position is responsible for creation, preparation and coordination of regulatory submissions and approvals to introduce new orthopedic implant products in the domestic and international markets. This includes interpretation of relevant government regulations.

Essential Duties and Responsibilities:

· Understand and interpret regulatory requirements in various geographies

· Prepare document packages for regulatory submissions including 510(k)s Design Dossiers, Device License Applications, Investigational Device Exemptions, and Pre-market Approval applications

· Direct and organize regulatory submission activities to ensure timelines and commitments are met

· Integrate responses to regulatory agencies and notified bodies as part of the submission and approval processes.

· Draft abstract/bench papers for publications

· Review and approve Engineering Change Orders in accordance with regulatory requirements

· Facilitate internal compliance with regulatory requirements for product development and be an integral part of the product development teams.

· Review and approve test protocols to support regulatory submissions

· Oversee device labeling and advertising material for compliance with submissions

· Collaborate in Regulatory compliance activities

· Maintain regulatory files

· Perform Internal Audits of the Quality System

· Other duties as assigned

Qualifications:

Bachelor degree in Engineering or Science. Advanced degree preferred.

Experience writing abstracts, bench/clinical papers

3+ years of relevant industry experience

Knowledge of applicable domestic and international regulations

Regulatory Submission experience in various geographies

Regulatory compliance experience in the medical device area preferred

Skills, Abilities, Competencies Required:

Must have strong verbal and writing communication skills

Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail.

Demonstrated understanding of regulations and guidelines for development, manufacturing and labeling of medical devices.

Demonstrated knowledge of GMPs and GCPs