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Form of work Position Details:
Our client, a world-leading Pharmaceutical Company in West Chester, PA is currently looking for a Regulatory Affairs Specialist / Medical Devices to join their expanding team.
Job Title: Regulatory Affairs Specialist / Pharma-Medical Devices
Duration: 6 months contract, extendable up to 24 months
Location: West Chester, PA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Prepares and submits Medical Device and/or Health Authority Reports within the required timelines.
Responsible and accountable for the accuracy of submitted regulatory reports.
Prioritizes work according to needs of department to support regulatory reporting and complaint investigation timeliness.
Responds to regulatory requests within requested
timeframes.
Assists in the review of daily reports Interacts with related agencies as requested.
Familiarity with applicable regulations for reporting. Interacts positively with internal/external business partners and colleagues.
Adheres and complies to work instructions, standard operating procedures, and regulations.
Participates in tracking metrics for department.
Achieves productivity targets.
Participates in CAPA/NC/DR activities and can act as task owner as required.
Assists with assignments of activities to meet deadlines.
Maintains current training records.
Proactive collaboration and resolution to cross-functional issues with stakeholders. Participates in interview process for selection of new hires.
All other duties as assigned by management.
Our client, a world-leading Pharmaceutical Company in West Chester, PA is currently looking for a Regulatory Affairs Specialist / Medical Devices to join their expanding team.
Job Title: Regulatory Affairs Specialist / Pharma-Medical Devices
Duration: 6 months contract, extendable up to 24 months
Location: West Chester, PA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Prepares and submits Medical Device and/or Health Authority Reports within the required timelines.
Responsible and accountable for the accuracy of submitted regulatory reports.
Prioritizes work according to needs of department to support regulatory reporting and complaint investigation timeliness.
Responds to regulatory requests within requested
timeframes.
Assists in the review of daily reports Interacts with related agencies as requested.
Familiarity with applicable regulations for reporting. Interacts positively with internal/external business partners and colleagues.
Adheres and complies to work instructions, standard operating procedures, and regulations.
Participates in tracking metrics for department.
Achieves productivity targets.
Participates in CAPA/NC/DR activities and can act as task owner as required.
Assists with assignments of activities to meet deadlines.
Maintains current training records.
Proactive collaboration and resolution to cross-functional issues with stakeholders. Participates in interview process for selection of new hires.
All other duties as assigned by management.
