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Regulatory Compliance Specialist Job
Date: May 2, 2013
Location: Allendale, NJ, US
|Job Title:||Regulatory Compliance Specialist|
|Business Sub Function:||Systems/Process Engineering|
|Job Description:||Evaluate customer complaints for reportability to FDA and other Compenet authorites under MDR/MDV regulations and submit reports within specified timeframes. Also, to provide assistance to the CAPA team in investigating, controlling and monitoing non-comformities to ensure they are dealt with in an efficent and effective manner in compliance to regulations, procedures, and standards applicable to Stryker Spine.|
- Follow-up with Sales Reps and Hospitals to obtain applicable information pertaining to reported events.
- Coordinate obtaining medical opinions in support of reporting and field actions.
- Manage, and lead the resolution of nonconformities and corrective/preventive actions (CAPA).
- Obtain product function and risk assessment information in collaboration with engineers to determine reportability.
- Review PERs for reportability to the FDA and other competent authorities under Medical Device Reporting regulations.
- Ensure timely completion of MDR rationales and initial, supplemental and final incident reports to FDA and other competent authorities within specified timeframes.
- Coordinate with QA all documentation required to reach a decision regarding a field action as required by Corp and Spine policies and procedures.
- Perform all activities, communication and documentation required to conduct and conclude a field action in the US.
- Notify FDA of reportable field actions and submission and follow up of all required documentation.
- Maintain training and awareness of related US federal regulations pertaining to Medical Device Reporting and recall activities.
- Perform training for in-house and field personnel on Customer Complaints, MDR/MDV reporting, and How to conduct investigations related to CAPAs.
- Prepare ad-hoc reports of MDRs and MDV’s as required.
- Participate in special projects and perform other miscellaneous duties as required.
- Minimum 1 to 3 years experience in a medical device industry analyzing product complaints for reportability to the FDA and other competent authorities.
- Ability to understand and explain detailed regulatory compliance programs or issues and comply with constantly changing regulatory requirements.
- Demonstrated applied knowledge of FDA and international medical device regulations/standards/directive applicable to spinal implants and instruments (ISO 13485, ISO 14971, 21CFR820, 93/42/CE, cGMPs)
- Demonstrated problem-solving and troubleshooting skills, including use of root cause analysis and Risk mitigation tools such as Failure Modes Effect Analysis (FMEA), SPC, Root Cause Analysis, and Mistake Proofing/Poka Yoke.
- Demonstrated ability to effectively work cross functionally with other departments including Operations, Research & Development, Regulatory Affairs, and Marketing.
- Demonstrated interpersonal and communication skills.
- Demonstrated ability to exhibit a positive, energetic approach to teamwork.
- Demonstrated ability to advocate product excellence and quality.
|Percent Travel Required:||10%|
Nearest Major Market: New Jersey
Job Segments: Compliance, Regulatory Affairs, Engineer, Law, CAPA, Legal, Engineering, Management
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