Sr Regulatory Reporting Specialist - 26432BR - EN in Mahwah, NJ at Stryker Corporation

Date Posted: 4/5/2018

Job Snapshot

Job Description

The Regulatory Reporting team assesses all incoming product complaints to identify adverse events (deaths or serious injuries) or situations (device malfunctions/use errors) that may result in adverse events and submit reports to FDA, European Competent Authorities, and BSI within strict time-lines. This critical function assures the company’s compliance with the FDA’s Medical Device regulations (MDR) and the European MEDDEV (MDV) requirements as well as assuring public safety by identifying potential product problems and assuring they are promptly addressed. Additionally, the Regulatory Reporting team addresses inquiries from various Regulatory Agencies through direct communications and various audits.
  • Review reports of customer complaints and assess them for MDR / MDV reportability to FDA / Competent Authorities
  • Ensure initial and follow up reports are submitted to Regulatory Agencies within required timelines.
  • Review and approve regulatory filing decisions.
  • Interact with Regulatory Agencies to assure their questions are addressed within established time-frames
  • Partner with Quality Complaint-Handling personnel to assure the complaint records contain all required information to make a compliant regulatory decision
  • Ensure complaints are classified correctly and that all supporting data are adequately documented and attached to the complaint file
  • Act as mentor for less experienced employees in the area of adverse event reporting
  • Update current procedures/processes or create new procedures/processes
  • Work from verbal and/or written instructions
  • Track metrics on process timeliness and effectiveness
  • Participate and/or lead process improvement projects
  • Train and mentor new and/or less experienced employees as well as cross functional partners in the process
  • May provide adverse event reporting data for product recalls and recall communications.

Job Requirements

  • 3+ years experience as a Regulatory or Quality professional in a regulated manufacturing environment, preferably Medical Devices/Pharmaceuticals
  • Ideal candidate will demonstrate applied knowledge of US and International Medical Device Regulations and Standards including but not limited to: FDA: CFR 21 Part 803 (MDR), and CFR 21 Part 820 (QSR), MEDDEV 2.12-1 (Guidelines on Medical Device Vigilance System), ISO 13485 (International Organization for Standardization), etc.
  • Experience with MDR/MDV reporting
  • Demonstrated organizational, problem-solving, analytical and time management skills
  • Demonstrated interpersonal skills required to interface with technical and non-technical personnel at all levels of the organization
  • Demonstrated ability to effectively communicate through written and oral means on behalf of the department
  • Ability to respond to the urgent needs of the department as well as the ability and versatility to adapt to changing priorities.
  • Proven track-record for meeting deadlines and delivering results
  • Experience in technical/procedure writing is preferred
  • Demonstrated ability to exhibit a positive, energetic approach to teamwork.
  • Proficient with Microsoft Office and ability to learn Corporate systems
  • Proficiency with TrackWise is preferred.
  • Ability to read and interpret Engineering schematics / drawings / prints is preferred.
  • Positive, energetic approach to teamwork and an advocate for quality.

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team