047086-EU-Medical Devices Regs Practice Leader–Digital Engineering Services-Chicago Location

About Capgemini

A global leader in consulting, technology services and digital transformation, Capgemini is at the forefront of innovation to address the entire breadth of clients� opportunities in the evolving world of cloud, digital and platforms. Building on its strong 50-year heritage and deep industry-specific expertise, Capgemini enables organizations to realize their business ambitions through an array of services from strategy to operations. Capgemini is driven by the conviction that the business value of technology comes from and through people. It is a multicultural company of 200,000 team members in over 40 countries. The Group reported 2017 global revenues of EUR 12.8 billion (about $14.4 billion USD at 2017 average rate).

Visit us at www.capgemini.com. People matter, results count.

Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.

This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship. 

Click the following link for more information on your rights as an Applicant – http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law

 
  

Prefer Chicago Location

Principal Duties and
Responsibilities

  • In
    an ever changing regulatory world, interpret & assess domestic and global
    regulatory requirements and make recommendations based on the specific region
    to management to ensure new products, new features and capabilities are
    effectively and compliantly introduced to global markets.

  • While
    project leading a small team, prepare and submit regulatory submissions,
    submission responses- ie: FDA, STeD Documents, 510(k), Technical Dossier, Licenses,
    and Registrations for global submissions.

  • Plan
    and coordinate strategic dossier preparation across regions for registration of
    products (US & EU), including authoring and publishing electronic
    submissions.

  • Develop
    approaches and methodologies based on established, changed and new legislation,
    regulation and guidance documentation. Specifically with the new EU MDR
    requirement.

  • Will
    stay abreast of all pertinent regulatory affairs issues. Interprets and applies
    FDA regulations to business practices and provides regulatory input, advice and
    guidance to the organization

  • Works
    out Regulatory scenarios to support decision making in line with Regulatory
    strategy.

  • Other
    responsibilities include providing regulatory support for currently marketed
    products, including the review and approval of engineering drawings, labeling,
    technical files, design history files, and engineering change orders.

  • Will
    be responsible for interacting with regulatory authorities as necessary.

  • Will
    be responsible for active follow-up on the progression of all Regulatory
    activities required to successfully and timely complete the Regulatory
    deliverables

  • Reviews
    proposed labeling for compliance with applicable US and international
    regulations

  • Reviews
    and evaluates promotion and advertising material for compliance with
    regulations

     

    Overall Requirements:

  • A
    minimum of 5 years of industry experience with a minimum of 10 years of
    experience in Regulatory Affairs

  • The
    ability to not only understand the new EU MDR requirements, but to come up with
    a strategic plan on what the client will need to do to meet the requirements
    moving forward

  • Advanced
    experience preparation of dossiers/submissions & experience with US FDA IDE
    and PMA submissions and knowledge of FDA regulations and regulations outside
    the US (EU).

  • Knowledge
    of overall business environment, the medical device industry and the
    marketplace

  • Mastery
    of relevant regulations pertinent to medical devices

  • Able
    to identify risk in regulatory strategies

  • Ability
    to function well as a member of the team and build relationships between RA and
    other areas

  • Strong
    written, verbal and listening skills; ability to communicate effectively at
    multiple levels, including Regulatory agencies

  • Experience
    in Project Management

  • Demonstrated
    ability to be creative and flexible to change/improve working environment in
    broad context as well as ability to work in ambiguous situations and experience
    with change management

  • Effective
    experience handling of conflicting priorities in changing cross-departmental,
    global environment

Ref:

047086

Posted on:

December 18, 2019

Experience level:

Director

Education level:

Bachelor's Degree (�16 years)

Contract type:

Regular

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