Job description

About PSC Biotech

Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Description:

Project Manager for Vigilance

Are you ready to connect across multiple business and across multiple functional groups to shape the future of Medical Device Vigilance groups.? Do you like to plan, monitor project progress, and keep collaborators informed along the way?

We are excited to share that Global Health Authority Reporting team is looking for a Project Manager to support implementation of Medical Device Regulations changes within Europe.

Project work will be multi-faceted focusing on Medical Device Vigilance and Eudamed UKCA, Swiss MedDO (Medical Devices Ordinance) regulation changes across multiple MEDTECH divisions.

This position,

• As the Vigilance Project Manager, you will be a trusted partner to Senior Leadership team. You will connect with other working groups and communicate effectively enabling informed, end to end strategic decision making.

• You will be instrumental ensuring project success by being able to easily pivot focus from one action to another without losing attention to detail.

• Results oriented, the Vigilance Project Manager will understand Complaint Management and Medical Device Vigilance with have a proven track record for project implementation.

Key Responsibilities:

• Develop a coordinated plan to advance strategic projects in alignment with internal and external stakeholders.

• Ensure development and attainment of project objectives, along with defining success measures.

• Implement a governance structure and actively engage and communicate with executive sponsors and key partners, developing regular communications.

• Lead interdependencies and ensure integration with EUDAMED, UKCA and Swiss MDO teams' objectives.

• Drive risk identification, management and plans for resolution for Vigilance Process

• Drive robust Change & Communication strategies for strategic priority objectives.

• Lead team meetings, with accountability for agenda & content management.

Requirements

Experience, skills & proficiencies required:

A candidate for this role will have a proven background in Quality/ Compliance, Complaint Management and/or Health Authority Reporting.

You will also have extensive experience working cross-functionally to achieve goals and influencing without direct authority.

• A minimum of a bachelor's degree or appropriate business experience is required.

• Broad experience and knowledge of world-wide quality system regulations (e.g., MDR (Medical Device Regulation) EU 2017/745, FDA 803, 820; ISO 13485, ISO 14971) with a working knowledge of international Health Authority reporting requirements

• Outstanding organizational leadership – skilled at people leadership and organizational change is required.

• Confirmed ability to get results through leading others, organizing, prioritizing, and delegating workload is required.

• Communicating complex ideas in an uncomplicated way is essential for this position.

• Ability to foster team efficiency, cohesiveness, and work collaboratively in a complex environment with multiple, and demanding partners is required.

• Outstanding ability to collaborate with peers, leaders, and senior executives to build and implement strategies and drive decision-making is required.

• Certifications: PMP, FPX, Lean/Six Sigma are preferred.

• Excellent verbal and written communication skills are required.

#LI-MC1

Job Type: Full-time

Salary: €49,438.50-€90,767.19 per year

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Cork, County Cork: reliably commute or plan to relocate before starting work (required)

Education:

• Bachelor's (preferred)

Experience:

• Operations: 1 year (preferred)
• Project management: 1 year (preferred)

Reference ID: 12059

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