Regulatory Affairs Consultant

2 weeks ago


New York, United States Connect Life Science Full time

Regulatory Affairs Consultant Cambridge MA, Remote with occasional site time Medical Device 6 month contract - 40 hours per week Competitve hourly rate

A MedTech company based in Massachusetts specializing in Class 2 Medical Device solutions are looking to hire a contractor for a 6-month renewable contract to support with product submissions in multiple countries (US, EU).

The Role:

You will play a key role in ensuring compliance with the regulatory requirements and standards of their medical device products. Your expertise in US and EU regulations and quality management systems will drive regulatory strategy and ensure successful regulatory submissions.

Responsibilities:

Provide guidance and support to cross-functional teams in the interpretation and implementation of regulatory requirements, standards, and guidelines (e.g., FDA, EU MDR, ISO 13485). Work with R&D to ensure regulatory compliance is integrated into the device development life cycle. Prepare and review regulatory submissions, technical files, and design dossiers.

You:

Degree in a relevant field (Engineering, Life Science, Regulatory Affairs etc.) Solid experience of class 2 regulatory requirements for medical devices including a successful 510(k) previously. Familiarity with medical device development life cycle methodologies, risk management, and QMS. Strong knowledge of FDA, EU MDR and ISO 13485. Expereinced Contractor/Consultant

Please apply early with an up-to-date CV to arrange a call. Interviews commencing week of 6th May 2024 for a mid-May start date.


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