Regulatory Project/Program Manager (Product DNA ecosystem)

Overview

Remote
$85 - $90
Contract - W2
Contract - 12 Month(s)
No Travel Required

Skills

Product DNA
Regulatory Project Manager
Regulatory Program Manager
PLM
FDA
EU MDR

Job Details

Job Description:
  • As a key team member, the Sr. Regulatory Project Manager-Product DNA brings a leadership opportunity to make an impact supporting the Healthcare Product DNA Program; a major transformational program that will create a connected thread of non-transactional product data to support the entire product lifecycle. This will specifically drive changes and interfaces within our overall eco-system (PLM, MES and ERP). This program is planned as a multi- year program that will have multiple projects, waves of deployment.
  • Reporting to the Sr. Director - Product DNA Implementation Lead in Global Technology and Innovation, you will make a major impact across the entire enterprise is bringing the Healthcare Mission to our patients. We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customers.
  • We believe that when people from different cultures, genders, and points of view come together, innovation is the result and everyone wins. Healthcare walks the walk, creating an inclusive culture where you can thrive.
  • Product DNA is an ecosystem that creates a connected thread of product information, harnessing the collective ingenuity of employees across functions, enabling better collaboration with customers and partners, to rapidly deliver quality products and services, ultimately improving more patients' lives. The position location is within the United States.
A Day in the Life: As the Sr. Project Manager you will lead the Regulatory Workstream for the Healthcare Product DNA programs You will:
  • Serve as functional and process owner for workstream driving the day to day activities.
  • Lead requirement gathering and business process design. Establish the data flow and a design that maximises individual and organizational efficiency.
  • Lead the Regulatory Strategy Meeting and develop close working relationships with the Regulatory leadership team.
  • Integrate the Product-DNA plans with those being developed by the Regulatory team.
  • Monitor scope inter-dependencies with other workstreams or governed projects.
  • Responsible for workstream performance, risk management, and issue resolution.
  • Develop and monitor KPIs, scope, spend, savings and return on investment targets.
  • Lead and/or participate on teams to structure issues, perform analyses, evaluate
  • options, and develop recommendations on key process and system questions.
  • Identify and engage necessary functional and group-specific SME's.
  • Work with SMEs / OCM on stakeholder management, business process definition, change impacts and training.
  • Define acceptance criteria, develop test scripts for Usability Pilots and User Acceptance Testing.
  • Monitor progress at defined points to ensure work is delivered on time, within budget and meets or exceeds expectations
  • Collaborate with solution architects to determine development sequencing.
  • Participate in release planning, sprint/iteration planning and demos.
  • Participate in feature integration, testing, verifying delivered user stories against sprint/increment goals.
  • Champion Product DNA in a way that engages and excites the end user community.

Qualifications:
  • External Must Have: Minimum Requirements
  • Bachelors degree required
  • Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
Nice to Have:
  • Bachelor's degree and a minimum of 9+ years of relevant experience including broad multi-functional business experience along with 5+ years of project and/or people management experience, or - Master's degree and a minimum of 5 years of relevant experience including broad multi-functional business experience along with 3-5 years of project and/or people management experience.
  • Solid program manager experience with a drive for continuous improvement and a passion to be a change agent.
  • Strong leadership skills with proven record of managing successful projects/teams.
  • Experience implementing initiatives through effective influence management skills at multiple levels in the organization.
  • Must be comfortable with ambiguity, adept at change management, and capable of working in cross functional teams.
  • Excellent facilitation and issue resolution skills.
  • Experience leading efforts in an FDA/ISO regulated environment. - Familiarity with regulatory submissions (e.g. Q, 510K, PMA, UDI, FURLS, CE mark, BUDI, etc.) to governing bodies such as FDA, EU, Korea, China, etc., their local notified bodies and regulatory agencies.
  • Familiarity with the evolving regulatory landscape and how that needs to influence the data model attributes related to regulatory submission and device registration as well as the progression from manual submission towards automated submission between medical device companies and regulatory bodies.
  • Familiar with the connection between regulatory submissions needed with respect to product changes requiring updated GTS licensing.
  • Experience with medical device product development to ensure that regulatory issues are addressed as an integral part of the enterprise change control process.
  • Knowledge and understanding of EU MDR requirements
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.