Cer Technical Reviewer

Cer Technical Reviewer
Company:

Quantum World Technologies Inc.


Cer Technical Reviewer

Details of the offer

Title: CER Technical Reviewer

Job Location: Raynham, MA USA

Interview: Skype

Duration: Long Term Contract

Must Have:

Candidates should be within the Regulatory/Quality industry of clinical research and must have strong experience in writing and reviewing of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance (SSCPs) for medical devices as per MEDDEV 2.7/1 Rev 4 and MDR compliance.

Description:

The Technical Reviewer acts as a team member supporting and executing the CER processes for the assigned therapeutic areas within the medical device businesses within his/her scope of responsibility.

Roles & Responsibilities:

Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables.

Ensure compliance of operations with governing regulatory requirements.

Create, maintain and assume accountability for a culture of high customer service.

Responsible for ensuring compliant creation and reviewing of CEPs, CERs, SSCPs within the business in accordance to local procedures, client's guidelines and regulatory requirements.

Experience in authoring and reviewing of PMS plans, PMS reports, PMCF plans, PMCF Evaluation Reports is preferable.

Ensures the CEP, CER and SSCP files are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed.

He/She will develop, implement and manage an effective communication model for CERs/SSCPs with cross functional business partners

Efficiency in conducting literature searches for authoring various types of reports.

Should have working knowledge and retrieving complaints data from publicly available adverse event databases like FDA 510(K) MAUDE, MHRA, TGA, etc.

Assists in the development of schedules to ensure operating company CER/SSCP timelines are met.

Participates in workshops and on initiatives to help define processes globally and keep abreast of CER regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies

Supports and at times acts as an SME during audits and inspections pertaining to CER/SSCP processes and reports.

Will actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, Preclinical and Regulatory Affairs relating to the CER/SSCP process

Act as a writing coach, devise training programs

Get resolution on issues affecting project deliverables.

Eligibility Criteria:

Master's degree or Ph.D. in Life Sciences/Pharmacy/Clinical/Bio-medical Engineering

A minimum of 8-15 years' experience in medical device industry including medical writing is required for this position.

Strong verbal and written communication skills are required.

Experience within the medical device industry and knowledge of medical device regulations, requirements, evidence generation, and CER/SSCP document creation is required.

Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio-statistical methods is preferred.

Regulatory/Notified Body audit experience is preferred

Title: CER Technical Reviewer

Job Location: Raynham, MA USA

Interview: Skype

Duration: Long Term Contract

Must Have:

Candidates should be within the Regulatory/Quality industry of clinical research and must have strong experience in writing and reviewing of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance (SSCPs) for medical devices as per MEDDEV 2.7/1 Rev 4 and MDR compliance.

Description:

The Technical Reviewer acts as a team member supporting and executing the CER processes for the assigned therapeutic areas within the medical device businesses within his/her scope of responsibility.

Roles & Responsibilities:

Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables.

Ensure compliance of operations with governing regulatory requirements.

Create, maintain and assume accountability for a culture of high customer service.

Responsible for ensuring compliant creation and reviewing of CEPs, CERs, SSCPs within the business in accordance to local procedures, client's guidelines and regulatory requirements.

Experience in authoring and reviewing of PMS plans, PMS reports, PMCF plans, PMCF Evaluation Reports is preferable.

Ensures the CEP, CER and SSCP files are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed.

He/She will develop, implement and manage an effective communication model for CERs/SSCPs with cross functional business partners

Efficiency in conducting literature searches for authoring various types of reports.

Should have working knowledge and retrieving complaints data from publicly available adverse event databases like FDA 510(K) MAUDE, MHRA, TGA, etc.

Assists in the development of schedules to ensure operating company CER/SSCP timelines are met.

Participates in workshops and on initiatives to help define processes globally and keep abreast of CER regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies

Supports and at times acts as an SME during audits and inspections pertaining to CER/SSCP processes and reports.

Will actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, Preclinical and Regulatory Affairs relating to the CER/SSCP process

Act as a writing coach, devise training programs

Get resolution on issues affecting project deliverables.

Eligibility Criteria:

Master's degree or Ph.D. in Life Sciences/Pharmacy/Clinical/Bio-medical Engineering

A minimum of 8-15 years' experience in medical device industry including medical writing is required for this position.

Strong verbal and written communication skills are required.

Experience within the medical device industry and knowledge of medical device regulations, requirements, evidence generation, and CER/SSCP document creation is required.

Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio-statistical methods is preferred.

Regulatory/Notified Body audit experience is preferred


Source: Dice


Area:

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