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Regulatory Compliance Associate Job
Date: May 5, 2012
Location: Mahwah, NJ, US
Requisition ID: 18382BR
Job Title: Regulatory Compliance Associate
Division: Orthopaedics
Business Functions: Regulatory Affairs
Focus Area Regulatory Affairs
Country: United States
State: NJ
City: Mahwah
Shift: N/A
Job Description:
Evaluate complaints to determine if MDR/MDV reports are required to FDA and Competent Authorities.
- Review reports of customer complaints and assess them for MDR / MDV reportability to FDA / Competent Authorities.
- Ensure reports to FDA / Competent Authorities are completed within required timelines.
- Submit initial and follow-up reports to device related Agencies as appropriate
- Interact with device related Agencies on vigilance reports and incidents
- Request information from the field to ensure all pertinent information is acquired to make adequate MDR/MDV decision.
- Work with customers and sales forces to resolve complaint issues.
- Work with Quality complaint-handling personnel.
- Review and analyze data for trending purposes.
- Work from verbal and/or written instructions.
- Responsible for providing assistance in developing applicable policies and procedures.
- Participate in process improvement and automation.
- All other tasks and responsibilities as assigned by the Manager.
Qualifications/Work Experience: • 1+ years experience as a Regulatory or Quality professional in a regulated manufacturing environment. Prefer experience with MDR/MDV reporting.
- General knowledge of FDA and international medical device regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.)
- Demonstrated ability to effectively work cross functionally with technical and non-technical personnel in other departments including Operations, Product Development and Marketing.
- Demonstrated interpersonal, oral and written communication skills a must.
- Demonstrated ability to exhibit a positive, energetic approach to teamwork.
- Ability to advocate product excellence and quality.
- Ability to read and interpret Engineering schematics / drawings / prints.
- Demonstrated results orientation and ability to learn quickly.
- Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
- Computer proficiency with MS Office and the ability to learn Corporate systems
- Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines.
Education and/or Special Training: Bachelor’s Degree in Science, Engineering or related field of study preferred.
Percent Travel Required: 5%
Job Title: Regulatory Compliance Associate
Division: Orthopaedics
Business Functions: Regulatory Affairs
Focus Area Regulatory Affairs
Country: United States
State: NJ
City: Mahwah
Shift: N/A
Job Description:
Evaluate complaints to determine if MDR/MDV reports are required to FDA and Competent Authorities.
- Review reports of customer complaints and assess them for MDR / MDV reportability to FDA / Competent Authorities.
- Ensure reports to FDA / Competent Authorities are completed within required timelines.
- Submit initial and follow-up reports to device related Agencies as appropriate
- Interact with device related Agencies on vigilance reports and incidents
- Request information from the field to ensure all pertinent information is acquired to make adequate MDR/MDV decision.
- Work with customers and sales forces to resolve complaint issues.
- Work with Quality complaint-handling personnel.
- Review and analyze data for trending purposes.
- Work from verbal and/or written instructions.
- Responsible for providing assistance in developing applicable policies and procedures.
- Participate in process improvement and automation.
- All other tasks and responsibilities as assigned by the Manager.
Qualifications/Work Experience: • 1+ years experience as a Regulatory or Quality professional in a regulated manufacturing environment. Prefer experience with MDR/MDV reporting.
- General knowledge of FDA and international medical device regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.)
- Demonstrated ability to effectively work cross functionally with technical and non-technical personnel in other departments including Operations, Product Development and Marketing.
- Demonstrated interpersonal, oral and written communication skills a must.
- Demonstrated ability to exhibit a positive, energetic approach to teamwork.
- Ability to advocate product excellence and quality.
- Ability to read and interpret Engineering schematics / drawings / prints.
- Demonstrated results orientation and ability to learn quickly.
- Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
- Computer proficiency with MS Office and the ability to learn Corporate systems
- Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines.
Education and/or Special Training: Bachelor’s Degree in Science, Engineering or related field of study preferred.
Percent Travel Required: 5%
Nearest Major Market: New Jersey
Job Segments: Business Process, Compliance, Customer Service, Engineer, Engineering, Healthcare, Law, Legal, Management, Medical Device, Orthopedic, Product Development, Regulatory Affairs, Research