Project Manager – Design Controls Remediation

Role Overview

An exciting opportunity for a Project Manager – Design Controls Remediation to join a leading medical device company based in the US. This role offers the chance to be part of a dynamic team driving critical compliance projects within a highly regulated environment. The successful candidate will play a key part in ensuring that remediation initiatives are managed effectively, aligning with quality standards and regulatory requirements.

In this position, you will oversee multiple project streams, collaborating closely with cross-functional teams to deliver project milestones on time and within scope. This is an excellent role for an accomplished project professional with a background in regulated industries seeking to make a tangible impact on product quality and compliance.

Key Duties And Responsibilities

Your duties as the Project Manager – Design Controls Remediation will be varied; however, the key duties and responsibilities are as follows:

• Develop and maintain the master project plan, including timelines, resource allocation, and milestone tracking across all remediation workstreams.
• Facilitate cross-functional meetings and decision-making forums to align stakeholders across engineering, clinical, quality, regulatory, and manufacturing.
• Monitor progress against deliverables, identify risks or delays, and implement corrective actions while ensuring traceability to design control elements.
• Prepare status reports, dashboards, and executive-level presentations to support internal leadership and regulatory readiness.
• As the Project Manager – Design Controls Remediation, you will ensure projects are executed efficiently, maintaining compliance with all relevant standards and regulations.

Role Requirements

To be successful in your application to this exciting role as the Project Manager – Design Controls Remediation, we are looking to identify the following on your profile and past history:

• A Degree or higher level in a relevant field (e.g., Biomedical Engineering, Quality Assurance, Regulatory Affairs).
• Proven experience supporting or leading remediation initiatives within regulated environments, particularly in medical device or pharmaceutical sectors.
• Strong knowledge of design controls and Design History File (DHF) requirements.
• Proven leadership, communication, and stakeholder management skills.

WHAT’S IN IT FOR YOU?

This position provides an excellent platform to lead impactful projects within a cutting-edge medical device organisation. You will gain valuable experience in regulatory compliance and remediation, working alongside industry experts in a supportive environment. Our client values innovation and commitment, offering opportunities for professional development and growth.

Key Words: Project Manager / Design Controls / Remediation / Medical Device / FDA / Regulatory Compliance / DHF / Quality Assurance / Cross-functional Teams / _Project Planning

_"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career."