Regulatory Affairs Associate

Lake Forest, IL

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as a Regulatory Affairs Manager in Lake Forest, Illinois. The Regulatory Affairs Manager is responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 

RESPONSIBILITIES

  • Manages technical file changes, reviews labeling changes for completeness and suitability for submission
  • Receive documents from various sources and review for completeness and suitability for submission to FDA
  • Reviews engineering change requests to assess impact to regulatory submissions
  • Responsible for writing import authorization memos to release ship flags to international countries
  • Assure the regulations and laws regarding 510(k) and PMA submissions meet compliance
  • Assure Technical and QA have approved the product, and that the labeling of the product meets the regulations for interstate shipment
  • Review technical documentation with a critical eye for typos, grammatical errors, etc.

EXPERIENCE

  • Capable of assessing product changes and determine regulatory impact
  • A minimum of three years of work experience
  • Experience in post-market regulatory tasks
  • Strong knowledge of change control process
  • Understanding of scientific disciplines required
  • Understanding of FDA regulations governing 510(k)s, PMAs, Software cybersecurity requirements, submission processes, and submission content
  • Understanding of international regulatory submission requirements for IVDs
  • Knowledge of engineering controls
  • Strong computer skills required

EDUCATION

  • Bachelor’s Degree required
  • Advanced Degree desirable

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.

847-267-1176