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Regulatory Compliance Specialist Job

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Stryker

Date: May 2, 2013

Location: Allendale, NJ, US

Requisition ID:20738BR
Job Title:Regulatory Compliance Specialist
Division:Spine
Business Unit:U.S.
Business Function:Engineering
Business Sub Function:Systems/Process Engineering
Country:United States
State:NJ
City:Allendale
Shift:1st
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.
Qualifications/Work Experience:
Percent Travel Required:10%


Nearest Major Market: New Jersey
Job Segments: Compliance, Regulatory Affairs, Engineer, Law, CAPA, Legal, Engineering, Management

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