Senior EUMDR Regulatory Affairs Specialist in Allendale, NJ at Stryker Corporation

Date Posted: 7/3/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Allendale, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    7/3/2018
  • Job ID:
    29259BR

Job Description

Plan, organize and implement strategies and activities required to support compliance to the European Medical Device Regulation (MDR) and alignment of quality and regulatory affairs documentation to the MDR requirements. Ensure compliance to all US and EU requirements and corporate/Spine policies and procedures regarding submissions and other requirements for market approval of medical devices. Participate in cross functional team activities from initial stages through securing regulatory approvals.  Apply scientific principles to understanding safety and efficacy on a wide range of products.  The Senior EU MDR RA Specialist will provide greater support to the group by taking on more projects of greater complexity under limited supervision. Will provide leadership and guidance to the Regulatory Affairs Specialists/Associates. May review work of less experienced Specialists/Associates and assist in their training plan and training.

  • Identify and assess gaps on existing documentation to the MDR
  • Provide strategic and tactical direction to cross functional teams for developing adequate documentation supporting compliance with MDR
  • Provide input into new and revised processes and documents for MDR compliance 
  • Create or modify Technical Documentation
  • Interface and coordinate with the Notified Body and other regulatory agencies on submissions, approvals or other issues
  • Plan, document and communicate an appropriate compliance strategy to support the implementation of MDR 
  • Participate on activities with external partners for MDR related documentation requirements
  • Maintain adherence to the MDR project schedule
  • Maintain well-organized records that allow ready retrieval of required information
  • Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers
  • Address and advise teams on appropriate pathways to market
  • Interpret existing and/or new regulatory requirements as they relate to company products and procedures.  Communicate this to appropriate personnel
  • Review and approve change control, manufacturing changes, etc. while considering global regulatory requirements
  • Communicate any regulatory body correspondence on submissions to the appropriate team(s) and RA management
  • Conduct labeling reviews and collateral material reviews. Responsible for English Master Matrix for IFUs. 
  • Assist with the development, implementation and maintenance of regulatory SOP's
  • Participate in continuous improvement activity and process re-engineering projects to increase the effectiveness of RA.

Qualifications

  • 4 year degree in scientific area preferred; RAC certification desired
  • Experience in preparation/review/submissions of Technical Files and Design Dossiers
  • Minimum 4 years of experience in FDA and EU regulated industry
  • Working knowledge of Medical Device Regulations (FDA and EU required, international a plus)
  • High level knowledge of Medical Device Design Controls, and product life cycle management, as well as applicable standards
  • Knowledge of Post-market surveillance and risk management techniques
  • Direct interaction with Notified Bodies and/or FDA reviewers/inspectors
  • Team based work environment experience preferred with leadership of teams
  • Strong interpersonal, written, oral, communication, organizational and planning skills
  • Working knowledge of personal computer systems and desktop office applications
  • Sound understanding of scientific principles

Work From Home: No

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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