Product Manager - SME Life Science (Complaints Non-Reg Affairs)

DETAILS

Country:United States

Office Location:Hamilton, NJ (US HQ)

Experience Level:5-8 years

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If you share a true passion for technology, enjoy working together in developing solutions, share ideas, and exchange knowledge we want to talk to you. Sparta Systems is the Leader in Enterprise Quality Management Solutions (EQMS) and moving forward!
The Product Manager - SME Life Science is focused on the identification and understanding of user requirements and the development of product requirements based on internal and external client feedback, direct observation and assessment of industry trends. The Product Manager - SME Life Science oversees the quality, design, experience and value of current products in the market as well as the next product in development.
Required Skills:
and Responsibilities:
  • Responsible for tracking and reporting on updates and proposes updates to regulations which affect life science and medical device companies.
  • Strong understanding and experience applying GxP quality processes including, but not limited to European Manufacturer Reports (EU MIR), Electronic Medical Device Reporting (EMDR), FDA Gateway, and Canadian Vigilance Reporting (CVR).
  • Strong understanding of quality metrics and key performance indicators (KPIs) and how they drive decisions across the life science industry.
  • Responsible for tracking and reporting on updates and proposes updates to regulations which affect life science and medical device companies.
  • Focuses on the development and identification of product requirements based on internal and external client feedback.
  • Focuses on the quality, design, experience and value of current products in the market as well as the next product in development.  
  • Strong understanding and experience applying GxP quality processes; experience with quality process optimization and “fit for purpose” quality processes across the product lifecycle; experience with KPI, metrics, and data reporting and analytics expectations within the quality space.
  • Works closely with the Product Management & Strategy team and other areas of the company to ensure that the long-term vision becomes a reality, by developing solutions that embody the key themes of our product direction.  
  • Applies domain experience in a creative and innovative manner in order to ensure that Sparta is building world class products in-line with client, market and government regulations on a global scale.
  • Leads all phases of a product program – from concept, through planning, development, go-to-market, launch and post-launch. Coordinates with program team members following a structured process and delivering artifacts that must be completed throughout the phases of software development lifecycle. 
  • Develop key product themes that are to act as the foundational messaging for marketing and other corporate constituents.  
  • Perform market studies in order to ascertain and validate the approach of the product/process.
Preferred Skills:
and Qualifications:
  • 5-10 years experience working in life sciences manufacturing, regulatory, quality, or R&D including the use of an eQMS software solution.
  • Strong understanding and experience applying GxP quality processes including, but not limited to European Manufacturer Reports (EU MIR), Electronic Medical Device Reporting (EMDR), FDA Gateway, and Canadian Vigilance Reporting (CVR).
  • Strong understanding of quality metrics and key performance indicators (KPIs) and how they drive decisions across the life science industry.
  • Successful completion of a Bachelor’s Degree in a relevant program of study, or equivalent work experience is required. 
  • Should be willing to travel <25% for customer meetings and project engagements.

Sparta Systems Offers:
    
  • Competitive salaries
  • 401k and great benefits package
  • An outstanding collaborative work environment in our state-of-the-art facility
  • Employee engagement programs such as Sparta Gives Back, Wellness, Spirit Committee, etc.
  • An opportunity to work for the world's premier provider of cloud and on-premise quality management software

About the Company:

Sparta Systems is the leading provider of Enterprise Quality Management Software (EQMS) solutions that drive and enhance quality and compliance for leading pharmaceutical, medical device, CPG and other companies globally. 

Founded in 1994, Sparta has operated for over 20 years as the pioneer, innovator and thought leader within the EQMS space, with its flagship TrackWise and TrackWise Digital solutions serving as the clear industry “gold standard”. The company has global operations, serving a diverse and loyal customer base of over 400 companies across the pharma, medical device, consumer and manufacturing sectors in the US, Europe and Asia, including 44 of the top 50 pharmaceutical companies in the world and 13 of the top 15 global medical device companies. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle.

Sparta is currently partnered with New Mountain Capital (“NMC”), a leading growth-oriented investment firm. NMC is interested in continuing to drive the company’s existing organic and inorganic growth opportunities within both existing and adjacent markets. 

Life is short… Work somewhere outstanding… Sparta Systems!

Sparta Systems in an Equal Opportunity Employer with our Headquarters located in Hamilton, NJ, USA
 
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