Senior Regulatory Reporting Specialist
Excellent salary & private healthcare, pension and bonus
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
Qualifications, skills and desirable experience
* Bachelor's Degree in Science, Engineering, Legal, or Regulatory and/or 3+ years experience as a Regulatory or Quality professional.
* 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.
If you are interested and feel you have relevant experience then please contact Rosie Carden for a confidential discussion on 01707 247259.
Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.