Regulatory Affairs Consultant Jobs

Regulatory Affairs Consultant

Remote/Hybrid with site visits to Boston, MA

Medical Device & IVD Experience

6 month contract

An innovative MedTech company based in Boston, MA specializing in Software as a Medical Device (SaMD) solutions and In Vitro Diagnostics are looking to hire a contractor for a 6-month renewable contract to support with product registrations under the MDR. Their devices provide diagnosis, monitoring, and treatment.

The Role:

You will play a key role in ensuring compliance with the regulatory requirements and standards of their SaMD and IVD products. Your expertise in regulations relating to SaMD/IVD will drive regulatory strategy and completing regulatory submissions.

Responsibilities:

• Prepare and review regulatory submissions, technical files, and design dossiers.
• Lead pre-sub and submissions from a technical point of view and be key point of contact internally and externally
• Liaise directly with FDA to ensure successful 510K and product clearance
• Provide guidance and support to cross-functional teams in the interpretation and implementation of software regulatory requirements, standards, and guidelines
• Work closely with Quality & Clinical teams to ensure all activities related to product and systems meet regulation/standards

You:

• Familiarity with software development life cycle methodologies, risk management, and QMS.
• Experienced Contractor/Consultant
• Degree in a relevant field (Engineering, Life Science, Regulatory Affairs etc.)
• Strong knowledge of FDA
• Experience in IVD
• Solid experience of software and SaMD regulatory requirements for medical devices

Please apply early with an up-to-date CV to arrange a call. Interviews commencing week of 17th July.