An Engineering Program Manager provides support and/or lead teams through the Engineering development process and implementation of companys products. Projects are typically shorter-term, less complex and more contained with a defined time frame.
Roles & Responsibilities
Understanding the guidelines, regulations and regulatory processes of each country is challenging especially for complex molecules with dynamic and evolving regulatory landscape.
Medical Product regulatory agencies from the USA (US-FDA), European Union (EMA), Australia (TGA), Canada (Health Canada), Japan (PMDA); and countries from Middle East (S. Arabia, Jordan, Turkey); Pan-American (Brazil, Mexico, Argentina), South Asian (S. Korea, Taiwan, Malaysia), Russian Federation (Russia, Ukraine), African (S. Africa, Algeria) regions have unique country specific submission/review procedures for approval
Development and Implementation of regulatory strategies for global registrations for products within the LLC Global portfolio
Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of LLC Global products.
Collaboration with partners to develop and execute global regulatory activities.
Wellness for All
Plan and manage development of high-quality regulatory documents, including briefing documents, DHF, Risk Management and all the supporting documents, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements.
Provide regulatory direction on global regulatory requirements to support product development.
Ensure all filings are maintained as per regulatory requirements and consistent with LLC Global strategy throughout product development and life cycle.
Support development and execution of clinical/non-clinical strategies.
Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans
With minimal supervision, participate in development of risk management and contingency planning.
Ensure and lead regulatory compliance for Lourdes Lifecare Global products.
Participation in regulatory meetings with Government, Regulatory, Labs Authorities
Key Skills
Lean, or Process Excellence certification is preferred. CAPA and Project Management ISO 14971 (risk management), IEC 62366 (usability engineering), IEC 60601-1-2 (EMI EMC), IEC 62304 (software lifecycle process), ISO 13155 (clinical investigation) Certified Lead Auditor- ISO 13485, Sig Sigma Green Belt and Project
Management (PMP) with extensive knowledge
Understanding of Regulatory activities
Ability to understand and communicate technical information. Anticipate and prevent potential issues.
About the Company
Lourdes Lifecare was founded with an innate need to provide reliable, affordable and quality medical products to all sections of society.
