Regulatory Work steam Lead/Project Manager

Regulatory Work steam Lead/Project Manager

Job Location- Remote

Long Term

Candidate should have below skill sets (Mandatory)

PLM (Product Lifecycle Management) Deep understanding of how PLM systems operate in a complex enterprise environment.

Windchill Specific experience with PTC Windchill, which is the platform Medtronic is standardizing on.

Medtronic Familiarity with Medtronic's organizational structure, processes, and culture.

Regulatory Strong knowledge of global medical device regulatory requirements, processes, and data needs.

A Day in the Life:

As the Sr. Project Manager you will lead the Regulatory Workstream for the Medtronic Product DNA program. 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

Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant 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