• Product Compliance Manager Jobs in United States Of America - 25297939

  • United States Of America, Usa
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  • 2 - 5 Years
  • Posted : above 1 month

Job Description:

Product Compliance Manager - 19001JDY

Preferred Qualifications

Oracle SSU

Product Compliance Manager

The Product Compliance Manager will manage product compliance projects for the Oracle Study Start-up (SSU) group The SSU software products drive business value in a highly regulated industry and this critical function ensures that our products are developed in a quality fashion that is adherent to industry requirements This role will ensure key functions in the software development process have been completed and include requirements definition, test cases authoring and execution and product review Additional responsibilities include ensuring customer inquiries and assessments are completed in a timely fashion and well communicated across the organization This role reports to the VP Product Management, Oracle SSU


Manages product compliance function, including coordination across resources to pull together quarterly release compliance package including product requirements, test cases, objective evidence, risk assessments, etc
Manages product compliance activities with Customer Services, Development, Engineering, Quality, and other groups on projects
As required, creates technical and compliance documentation as part of release packages
As required, prepares regulatory submissions and presents validations to key representatives during routine internal and pre-approval inspections
Ensures solutions are consistent with organizational objectives
Coordinates and implements changes to controlled documents (eg, SOPs, Specifications, Methods, etc) as needed

Qualifications Experience with Agile software development process and JIRA project management
Familiarity with life science regulatory like 21 CFR Part 11, HIPPA, and GDPR preferred
Strong communication and project management skills including leadership through influence
Strong technical writing skills and detail orientation
Able to troubleshoot solutions to complex problems, which requires ingenuity, creativity and innovativeness
Interprets, executes, and recommends modifications to company-wide policies to achieve corporate goals and objectives
Comfortable interacting customers on audits as needed and possesses the ability to represent Oracle SSU with external parties as needed
2 years of relevant experience and bachelors degree in science or related field preferred

Detailed Description and Job Requirements

Work as part of a team that acts as the central resource and driving force for the design, process, manufacturing, test, quality and marketing of product(s) as they move from conception to distribution Organize interdepartmental activities ensuring completion of the project/product on schedule and within budget

As a member of the product development division, you will define product specifications and or strategy Gather and analyze information to define product specifications and review design specifications Communicate product strategy and functionality Initiate and foster relationships with other groups Review product documentation and collateral Ensure successful product releases based on corporate priorities

Duties and tasks are standard with some variation; displays understanding of roles, processes and procedures Performs moderately complex problem solving with assistance and guidance in understanding and applying company policies and processes BS degree or equivalent experience relevant to functional area 1 year of software engineering or related experience

Oracle will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of San Franciscos Fair Chance Ordinance

Oracle is an Affirmative Action-Equal Employment Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veterans status, age, or any other characteristic protected by law

Job Product Development

Travel No

Location US-CA,California-San Francisco

Job Type Regular Employee Hire

Organization Oracle

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Software Services, IT-Software
Functional Area : IT Software : Software Products & Services
Role : Quality Assurance/Testing
Salary : As per Industry Standards
Deadline : 02nd Jun 2020

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