Regulatory Affairs Specialist

North Haven, CT

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Regulatory Affairs Specialist in New Haven, Connecticut. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity

RESPONSIBILITIES

  • Responsible for managing international regulatory registrations with the regional business units (RBU), which includes global regulatory strategies and impact assessments, initial registrations, re-registrations and notifications/registrations of changes that may impact the regulatory approvals
  • Assist with preparation of U.S. FDA submissions, Design Dossiers for European Union submissions, technical files, reviewing design control documents and change requests, and being an active member of design teams representing the regulatory affairs responsibility
  • Assist in the development, documentation, and implementation of regulatory strategies for new technologies and product modifications to include all applicable regulatory requirements
  • Prepare 510(k), Technical File, CE Mark, and other related regulatory filings
  • Support IDE and PMA submission preparation as requested
  • Collaborate with R&D to determine and execute pre-clinical test plans in support of regulatory submissions
  • Establish and maintain a professional and credible image with FDA, TUV, and other regulatory agencies
  • Provide regulatory affairs support to design teams and the document control/change request system
  • Maintain superior knowledge of competitive technologies in addition to medical and technical developments related to the client products
  • Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities
  • Oversee the submission of International Registration Documents, progress reports, supplements and amendments

EXPERIENCE

  • 2 to 4 years in the medical device industry
  • Demonstrated experience in preparing 510(k) submissions for FDA, experience with Class III devices are a plus
  • Demonstrated experience with submission to the European Union
  • RAC preferred

EDUCATION

  • Bachelor’s Degree in health profession, science and/or engineering field

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately

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