Role overview

Qualifications

Bachelor’s degree in Engineering, Life Sciences, Project Management, Business, or a related field
Proven experience managing projects in a regulated medical device, biotechnology, or pharmaceutical environment
Strong understanding of product development processes, design control, and risk management (ISO 14971)
Proficiency with project management tools such as MS Project, Smartsheet, or equivalent

Responsibilities

Lead planning and execution of medical device product development and commercialization projects from concept through launch
Define project scope, objectives, deliverables, and success criteria with cross-functional stakeholders
Develop and maintain detailed project plans, timelines, resource allocations, and budgets
Serve as primary liaison among RD, Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure seamless project execution

Key facts

Remote from: Anywhere
Fixed term
Project Director
English

Other skills

Accountability
Communication
Leadership
Organizational Skills
Analytical Thinking
Problem Solving

About the company

Pharmavise Corporation

Management Consulting

♦𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐮𝐚𝐥𝐢𝐭𝐲♦: 𝐏𝐡𝐚𝐫𝐦𝐚𝐯𝐢𝐬𝐞, 𝐲𝐨𝐮𝐫 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐆𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐩𝐚𝐫𝐭𝐧𝐞𝐫. 𝗔𝗯𝗼𝘂𝘁 𝘂𝘀 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻: We provide high-quality, cost-effective people and process solutions for your Quality, Regulatory, Engineering, Clinical, and Healthcare needs. Our company mantra 𝐄𝐗𝐂𝐄𝐋𝐋𝐄𝐍𝐂𝐄 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐔𝐀𝐋𝐈𝐓𝐘. The safety and quality of the drugs and devices produced for patients are directly related to 2 things, 𝐑𝐎𝐁𝐔𝐒𝐓 𝐏𝐑𝐎𝐂𝐄𝐒𝐒 𝐚𝐧𝐝 𝐐𝐔𝐀𝐋𝐈𝐅𝐈𝐄𝐃 𝐏𝐄𝐎𝐏𝐋𝐄. 𝐖𝐞 𝐝𝐞𝐥𝐢𝐯𝐞𝐫 𝐛𝐨𝐭𝐡. 𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭𝐢𝐚𝐭𝐨𝐫𝐬: ☑𝐇𝐢𝐠𝐡𝐥𝐲 𝐒𝐤𝐢𝐥𝐥𝐞𝐝 𝐓𝐞𝐚𝐦: Our team of experienced consultants with diverse backgrounds in life sciences, including scientists, researchers, and regulatory experts. The quality and expertise of our team significantly impact our client’s success. ☑𝐒𝐩𝐞𝐜𝐢𝐚𝐥𝐢𝐳𝐞𝐝 𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞: We focus on specific niches within the life sciences, healthcare, and government sectors, such as pharmaceuticals, biotechnology, medical devices, regulatory affairs, medical research, and product development. This specialized expertise allows us to offer targeted and in-depth insights to our clients. ☑𝐂𝐮𝐬𝐭𝐨𝐦𝐢𝐳𝐞𝐝 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬: We offer tailored solutions that align with the specific requirements of each client, rather than one-size-fits-all approaches, demonstrating a commitment to meeting client needs. We do not require a long learning curve, which leads to a faster payback and a greater return on your investment. 𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗛𝗶𝘀𝘁𝗼𝗿𝘆 Over 20 Technical Transfers and 30 product launches. 11 FDA remediations. Warning Letters and or Consent Decrees. Cost savings and increased efficiency of over 10MM for clients

Company details

IndustryManagement Consulting

Company size11 - 50

Links

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Job description

This is a remote position.

We are seeking a talented and self-driven Project Manager to lead cross-functional programs within the medical device industry, ensuring projects are executed on time, within scope, and in compliance with regulatory and quality standards. This role requires strong leadership, organizational, and technical acumen to manage complex product development and lifecycle initiatives that support business objectives and patient safety.

The ideal candidate possesses a balance of strategic thinking and executional excellence, with the ability to collaborate across R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams. The Project Manager will be responsible for coordinating all aspects of project planning, execution, risk management, and reporting while ensuring adherence to FDA, ISO 13485, and global medical device regulations.

Key Responsibilities:

Lead the planning and execution of medical device product development and commercialization projects from concept through launch.
Define project scope, objectives, deliverables, and success criteria in collaboration with cross-functional stakeholders.
Develop and maintain detailed project plans, timelines, resource allocations, and budgets.
Ensure alignment between project goals and organizational strategy through effective stakeholder management.
Serve as the primary liaison among R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure seamless project execution.
Coordinate and track cross-functional deliverables, facilitating effective communication and issue resolution.
Lead project team meetings, design reviews, and phase-gate reviews, ensuring all actions and decisions are documented.
Drive accountability across teams to meet milestones and maintain compliance with design control and quality system requirements.
Ensure all project activities align with Design Control (21 CFR 820.30), ISO 13485, ISO 14971, and other applicable standards.
Partner with Regulatory and Quality teams to support technical documentation, risk management, and DHF maintenance.
Manage change control processes and ensure that design and process changes are properly evaluated, documented, and approved.
Identify potential project risks and mitigation strategies, maintaining proactive issue resolution throughout the project lifecycle.
Monitor project budgets, costs, and resource utilization, providing regular updates to leadership.
Ensure timely escalation of risks, delays, or quality concerns that could impact project deliverables.
Support the development and implementation of best practices, templates, and processes to enhance project management effectiveness.
Contribute to continuous improvement initiatives related to project governance, documentation, and cross-functional collaboration.
Leverage project metrics and lessons learned to improve execution efficiency and product quality outcomes.

Must-Have Qualifications:

Bachelor’s degree in Engineering, Life Sciences, Project Management, Business, or a related field.
Proven experience managing projects in a regulated medical device, biotechnology, or pharmaceutical environment.
Strong understanding of product development processes, design control, and risk management (ISO 14971).
Proficiency with project management tools such as MS Project, Smartsheet, or equivalent.
Demonstrated ability to manage multiple complex projects simultaneously.
Excellent communication, documentation, and stakeholder management skills.
Strong problem-solving, analytical, and organizational abilities.

Preferred Qualifications:

PMP, PRINCE2, or equivalent Project Management certification.
Experience with new product introduction (NPI), process validation (IQ/OQ/PQ), or post-market engineering projects.
Familiarity with MDSAP, EU MDR, and other international medical device frameworks.
Experience in Agile or hybrid project management environments.
Knowledge of resource planning, cost control, and vendor management in regulated product development.

This is intended for inclusion in Pharmavise’s talent database to build a qualified pool of professionals for future medical device client requisitions.