Regulatory Consultant Job

REGULATORY CONSULTANT needed for a CONTRACT opportunity with Yoh's client located in CAMBRIDGE, MA.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Medical Device
- PMA Submissions
- IVD

WHAT YOU'LL BE DOING:

- Development and maintenance of PMA submission trackers through the PMA life cycle
- Management development of submission documents with specific subteams
- Review documents
- Provide regulatory guidance to Subject Matter Experts(SMEs)/Authors
- Assist authors in prioritizing and resolving reviewer comments
- Review/approval of labels and reports in EtQ
- Preparation of PMA subtext outlines.
- Authoring documents in NovStyle
- Assembly and preparation of attachments/appendices/references
- FDA/CDRH E-sub formatting

WHAT YOU NEED TO BRING TO THE TABLE:

- Minimum Bachelors degree, advanced degree preferred
- Five (5+) years Medical Device regulatory experience
- PMA submission experience
- Excellent writing skills

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: PROF

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