<![CDATA[Legacy MedSearch: jobboards]]> http://JOBS.LEGACYMEDSEARCH.COM/ en-us <![CDATA[Regulatory Specialist - Hip]]> Position Overview

As a regulatory specialist for a major Orthopedics manufacturer you will prepare and maintain FDA & international product registrations for medical devices.

Primary Responsibilities:

  • Ensure that all procedures, processes, and documentation meet guidelines for FDA compliance, including Design Control & Risk Management processes
     
  • Prepare & Maintain FDA pre-market submissions as well as international product registrations
     
  • Prepare & Maintain CE Mark Design Dossiers and Technical File for review by the Notified Body
     
  • Provide regulatory support for new product development process
     
  • Participate in complaint handling process, internal quality audit process, and CAPA activities.
     
  • Review and approve product labelling
     
  • Provide support and guidance for other employees as necessary

Position Requirements:

  • 2+ Years Experience in FDA/ISO Medical Device Quality Management Systems
     
  • Experience in preparing FDA pre-market submissions (whether 510(k) and/or PMA) and international registrations highly preferred
     
  • Nuanced understanding in Design Control

Education Requirements:

  • Bachelors 

Location: Southeast

Compensation: Commensurate with Experience

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Thu, 12 Jul 2018 00:00:00 EDT 0
<![CDATA[Regulatory Specialist - Knee]]>

Position Overview

As a regulatory specialist for a major Orthopedics manufacturer you will prepare and maintain FDA & international product registrations for medical devices.

Primary Responsibilities:

  • Ensure that all procedures, processes, and documentation meet guidelines for FDA compliance, including Design Control & Risk Management processes
     
  • Prepare & Maintain FDA pre-market submissions as well as international product registrations
     
  • Prepare & Maintain CE Mark Design Dossiers and Technical File for review by the Notified Body
     
  • Provide regulatory support for new product development process
     
  • Participate in complaint handling process, internal quality audit process, and CAPA activities.
     
  • Review and approve product labelling
     
  • Provide support and guidance for other employees as necessary

Position Requirements:

  • 2+ Years Experience in FDA/ISO Medical Device Quality Management Systems
     
  • Experience in preparing FDA pre-market submissions (whether 510(k) and/or PMA) and international registrations highly preferred
     
  • Nuanced understanding in Design Control

Education Requirements:

  • Bachelors 

Location: Southeast

Compensation: Commensurate with Experience

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Thu, 12 Jul 2018 00:00:00 EDT FDA pre-market submissions (510(k)

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<![CDATA[Regulatory Specialist - Shoulder]]> Position Overview

As a regulatory specialist for a major Orthopedics manufacturer you will prepare and maintain FDA & international product registrations for medical devices.

Primary Responsibilities:

  • Ensure that all procedures, processes, and documentation meet guidelines for FDA compliance, including Design Control & Risk Management processes
     
  • Prepare & Maintain FDA pre-market submissions as well as international product registrations
     
  • Prepare & Maintain CE Mark Design Dossiers and Technical File for review by the Notified Body
     
  • Provide regulatory support for new product development process
     
  • Participate in complaint handling process, internal quality audit process, and CAPA activities.
     
  • Review and approve product labelling
     
  • Provide support and guidance for other employees as necessary

Position Requirements:

  • 2+ Years Experience in FDA/ISO Medical Device Quality Management Systems
     
  • Experience in preparing FDA pre-market submissions (whether 510(k) and/or PMA) and international registrations highly preferred
     
  • Nuanced understanding in Design Control

Education Requirements:

  • Bachelors 

Location: Southeast

Compensation: Commensurate with Experience

 

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Thu, 12 Jul 2018 00:00:00 EDT FDA pre-market submissions (510(k)

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<![CDATA[Regulatory Affairs Manager]]> Position Summary:

The Regulatory and Clinical Affairs Manager will be responsible for hands on contribution, cross functionally, towards gaining regulatory acceptance for products currently in the pipeline and future products.  

  • Degree in Engineering or Life Sciences
  • Minimum 3 years working in Regulatory Affairs in the Medical Device Industry
  • Experience in Ophthalmology is a plus
  • Knowledge of creating and writing 510(k) dossiers and managing a complete 510(k) registration process
  • Knowledge of FDA regulations
  • Knowledge of IEC 60601-1 Family, IEC 62304, IEC 60825 and ISO 14971
  • Excellent interpersonal skills
  • Ability to travel domestically and globally occasionally (30%)

*Due to the confidential nature of this position, please contact Joy Celebre for further information.


Location: Massachussetts

Position Reports To: VP Regulatory

Compensation: Commensurate

Travel: International

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Thu, 21 Jun 2018 00:00:00 EDT 1