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Biology Job USA | Regulatory Affairs Specialist Position @ MSD

Biology Job USA | Regulatory Affairs Specialist Position @ MSD

Biology Job USA | Regulatory Affairs Specialist Position @ MSD: Founded in 1995, Meso Scale Discovery (MSD) is a global leader in the development, manufacture, and commercialization of innovative assays and instruments for the measurement of molecules in biological samples. MSD’s proprietary MULTI‑ARRAY technology enhances medical research and drug development by enabling researchers to profile many biomarkers simultaneously in a single sample without compromising assay performance.

MSD’s technology is widely adopted by researchers in pharmaceutical companies, government institutions, universities, and clinical laboratories worldwide for its high sensitivity, excellent reproducibility, and wide dynamic range. Throughout its history, MSD has continued to evolve its technology platform to enable researchers to solve complex biological questions and, as the Company looks toward the future, it is expanding into clinical applications and the emerging fields of personalized medicine and companion diagnostics.

Biology Job USA | Regulatory Affairs Specialist Position @ MSD

POSITION SUMMARY:

The Regulatory Affairs Specialist II is responsible for the support of regulatory activities, including the submission and maintenance of regulatory filings, in accordance with MSD’s regulatory strategies.  Responsible for staying current with all applicable FDA and EU regulations and guidelines and advising MSD staff on regulatory matters, as needed.

DUTIES AND RESPONSIBILITIES:

  • Prepare regulatory submissions
  • Ensure submissions comply with applicable regulations and guidance documents
  • Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies
  • Track submissions and ensure timely filing of documents
  • Review technical portions of submissions
  • Coordinate responses to input from regulatory agencies
  • Serve as regulatory contact for external consultants for regulatory submission projects
  • Provide regulatory review of documents needed for project teams and products,

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in a Health or Science field
  • Minimum of five years of in vitro diagnostics regulatory affairs experience in an FDA-regulated environment
  • Experience in preparation and submission of 510(k) applications, clinical trials, FDA pre-submissions and written and oral communications with the FDA
  • Experience in both U.S. and international regulatory requirements

KNOWLEDGE, SKILLS AND ABILITIES

  • Strong knowledge of FDA and ISO regulations for in vitro diagnostic devices
  • Excellent oral, written communication and interpersonal skills
  • Effectively communicate with FDA, notified body, clinical sites, MSD project teams
  • Proficiency in MS Office Suite
  • Must work effectively with a team and individually
  • Excellent organizational skills and the ability to multi-task; detail oriented
  • Ability to evaluate regulatory documents and determine appropriate action

PHYSICAL DEMANDS:
This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.

Requisition Number: 15-0100
Title : Specialist II, Regulatory Affairs
City : Rockville
State :MD

Biology Job USA | Regulatory Affairs Specialist Position @ MSD

How to Apply : https://rew12.ultipro.com/MES1002/JobBoard/CanLogin.aspx?__JobID=*618CE142DD790209&__RT=*D356349294394CA3EAC10FEC2E7B083E592078D9E1CA018DE20B06EA3520AD3AC2629F3A29822DB9

View Original Notification: https://rew12.ultipro.com/MES1002/JobBoard/JobDetails.aspx?__ID=*618CE142DD790209

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