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Regulatory Support Manager

  • GE Healthcare
  • Experienced
  • Posted 7/26/2017 5:32:38 PM
  • 2935627
  • Job Function: Product Management
  • Business Segment: Healthcare Life Sciences
Location(s): United States; Massachusetts; Marlborough


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GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.



There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with
more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For
more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can.


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Learn More About Careers at GE Healthcare –
Life Sciences

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Role Summary:
The Regulatory Support Manager will have responsibility for providing support to Product
Managers, Regions and customers by providing quality documents and regulatory support in
response to customers’ requests for quality, regulatory and technical-related information. As a
member of the Customer Regulatory Support team, you will add value to biopharmaceutical
customers’ single-use products and demonstrate a commitment to customer satisfaction.

Essential Responsibilities:

  • Build and maintain knowledge and understanding of customers’ regulatory requirements
    related to the BioProcess business at a high level
  • Develop and update regulatory support documentation for products in customers’ regulated
    environments
  • Perform necessary investigations and prepare and deliver statements and certificates
  • Participate in creating and updating guidelines and steering documents
  • Act as regulatory support expert and discussion partner to R&D, QA, Product Management
    and other functions and regions
  • Participate in project teams as regulatory support expert
  • Lead cross-functional activities when required
  • Respond efficiently and promptly to customers’ regulatory based issues, which will include
    necessary investigations, preparations and delivery of certificates, use of available internal and
    external databases and other relevant databases
  • File and maintain complete documentation of questions and answers in databases; specify,
    prepare, update and review regulatory support documentation, including RSF, VG, VSF, HWPD,
    CCN, statements, certificates and other regulatory related documentation for new and existing
    products
  • Use existing web based system and expand regulatory supporting information provided on the
    Bonus Target Information - Country US Bonus Target Information - IFG GE Healthcare
    Daily Work Schedule - Friday 8 Daily Work Schedule - Monday 8
    Daily Work Schedule - Saturday 0 Daily Work Schedule - Sunday 0
    Daily Work Schedule - Thursday 8 Daily Work Schedule - Tuesday 8
    Daily Work Schedule - Wednesday 8
    web

Quality Specific Goals:

  • Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality
    Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job
    type/position
  • Complete all planned Quality & Compliance training within the defined deadlines
  • Identify and report any quality or compliance concerns and take immediate corrective action as
    required


Qualifications/Requirements:

  • Bachelor of Science degree in Chemistry, Pharmacy or other related field
  • Three or more years of experience in the (bio)pharmaceutical industry or a related field
  • Understanding of GMP and knowledge of regulatory requirements in the (bio)pharmaceutical
    industry
  • Organized, target and customer oriented
  • Strong written and verbal communication skills
  • Flexible and service-minded with the ability to be collaborative
  • Strong ability to work independently


Desired Characteristics:

  • Five or more years’ experience with biopharmaceutical process development and quality
    assurance
  • Expertise in the medical regulatory field
  • Experience in GE Healthcare product development or production.
  • Experience leading cross-functional activities
  • Strong computer skills with prior experience in systems, including Microsoft Office products,
    Magic, Oracle and Lotus Notes


Locations: United States; Massachusetts; Marlborough

GE offers a great work environment, professional development, challenging careers, and competitive compensation.  GE is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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