Senior Regulatory Reporting Specialist in Elstree at Stryker Corporation

发布日期: 11/2/2019



Education and Special Training Required:

  • Bachelor’s Degree in Science, Engineering or related field of study and/or 3+ years experience as a Regulatory or Quality professional.   

Qualifications and Work Experience Required:

  • 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.

Review and assess all incoming product complaints according to the regulatory requirements governing MDR and/or MDV Reporting to determine if the event meets reporting criteria. Assure all required reports are completed and submitted to the applicable agency within the required time-frames. Address inquiries from various Regulatory Agencies through direct communications and various regulatory 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.

Work From Home: No

Travel Percentage: 10%