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Regulatory Affairs Manager

Lake Zurich, Illinois

Post Date: 06/21/2017 Job ID: 1463 Job Category: Clinical: Regulatory

Our client’ s purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.

We currently have two positions open for a Manager, Regulatory Affairs in our clients Medical Device Division who will be responsible for new and existing combination products, disposable medical products and/or software driven medical devices.

Job Responsibilities:
  • Author US and international registrations (510(k)s, PMAs, CE Mark, etc) of stand-alone medical device software and/or combination products
  • Assess product changes to determine regulatory impact on existing product licenses. 
  • Perform gap analyses and propose solutions
  • Represent regulatory on assigned cross-functional product and project teams and establish regulatory strategies that align with world-wide objectives.
  • Act as regulatory project manager on assigned projects; interact with subject matter experts to help ensure on-time, quality documentation for regulatory filing; drive to expected regulatory timelines. 
  • Review and approve product labeling and advertising for compliance to applicable regulatory requirements.
  • Act as liaison for Business Unit RA to Country RA interactions
  • Use your regulatory point of view to support clinical investigations


Qualifications/Requirements:
  • Bachelor’ s degree or equivalent experience in related scientific discipline/ computer science/ medical device Regulatory Affairs
  • 5 years regulatory experience in the medical device industry
  • Experience with Authoring 510(k) submissions
  • Expertise with device regulations
  • Ability to manage complex projects and timelines in a matrix team environment
  • Strong oral and written communication (English), technical writing and presentation skills
  • The following experience is desired and a plus: combination of pharmaceutical, disposable medical devices, medical device software, and combination product experience; previous Experience in product development/regulatory submission for a Class III medical device or a combination product; Experience with regulatory requirements and knowledge concerning clinical investigations; Knowledge of US regulatory requirements for software driven medical devices, stand-alone software, and Medical Mobile Apps; Expertise with biocompatibility standards and regulatory aspects of material qualification; Experience in the design/development of networked database applications;   Knowledge of computer networking technologies and/or computer hardware components; Knowledge or experience with Cybersecurity and/or Computer System Security Concepts.

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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