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Randstad Quality & Regulatory Consultant - EU MDR in Andover, Massachusetts

Quality & Regulatory Consultant - EU MDR

job details:

  • location:Andover, MA

  • salary:$38 - $43 per hour

  • date posted:Wednesday, January 15, 2020

  • job type:Contract

  • industry:Professional, Scientific, and Technical Services

  • reference:727904

job description

Quality & Regulatory Consultant - EU MDR

job summary:

Your challenge as a Quality, Regulatory and Compliance Contingent Worker is to support the EU MDR Program Management Office (PMO) to ensure that our business' quality plans are compliant with EU MDR regulation in preparation for the May 2020 deadline. Additionally, we are asking support in reviewing and compiling findings from internal audit reports in order to effectively identify potential problem areas for MDR compliance.

location: Andover, Massachusetts

job type: Contract

salary: $38 - 43 per hour

work hours: 8am to 5pm

education: Bachelors

responsibilities:

You are responsible for support of the EU MDR program management office to effectively & methodically execute:

o Quality Plan review: Support timeline for review of approximately 25 Quality Plans amended for EU MDR; provide critical regulatory, quality and EU MDR expertise; feedback and revision suggestions to our business leads, including identification of critical gaps as well as how those gaps should be addressed to be compliant with the new regulation.

o Internal Audit findings review: Support timeline for review of internal audit reports from all business units in order to identify trends and common gaps whereby the PMO may need to offer additional training and/or support.

o Maintains tools needed for effective execution of review as well as communication of project status such as action item trackers, timelines (in PowerPoint, Excel, and / or MS Project), etc.

o May include management of Sharepoint interface, structure, and relevance (internal-facing content).

o Key meeting preparation / execution / follow-up: May support development of objectives, agendas, content, and summaries for key program and management meetings, as well as effective follow-up and action item closure.

o Promotes consistency and alignment across Business Groups/Units

o Provides internal PMO feedback on content issues / approaches to quality planning within each BG as well as across Client/ process-department owners and support effective improvement steps.

o Communications: May support internal program and external Client communication, which includes content and planning for communications cascades, and supporting review / feedback.

qualifications:

To succeed in this role, you should have the following skills and experience

  • Bachelor/ Master degree in a technical discipline with experience in Quality, Compliance, and Regulatory Affairs, with a minimum of 8 years of experience in a similar role in the Medical Device industry (required)

  • Experienced with Software as a Medical Device would be preferred

  • Base understanding of appropriate global medical device regulations, requirements, and standards like ISO 14155, ISO 13485, ISO 14971, IEC 62304, IEC 82304, GCP, MDD, MEDDEV, MDSAP, EU MDR

skills: - Excellent verbal and written communication skills in English (required)

  • Willingness to contribute individually as well as lead program teams to meet project timelines and regulatory and clinical requirements

  • Self-directed with a strong work ethic, with an ability to work in a goal-oriented environment

  • Strong writing skills to produce quality documents

  • Experienced with successful preparation and submission of quality plans for regulatory body review.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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