Overview
On Site
Depends on Experience
Contract - Independent
Contract - W2
Contract - 6 month(s)
No Travel Required
Skills
PMP
SAP
Jira
Project Management
Agile
Scrum
SDLC
Healthcare
FDA
Medical Device
Change Management
IT integration
Six Sigma
risk management
ISO 13485
CSM
Stakeholder management
CAPM
Microsoft Project
Digital Transformation
Project Management Professional (PMP) or Certified Associate in Project Management (CAPM) PMI. Certified ScrumMaster (CSM) or Agile Certified Practitioner (PMI-ACP).
Healthcare experience
Regulatory Compliance
Audit Readiness
CAPA
Quality Systems
Job Details
Requirements:
- 5 or more years of experience of project management experience in regulated healthcare or medical device manufacturing.
- Proficiency in Project Management Professional (PMP) or Certified ScrumMaster (CSM) methodologies.
- Experience with FDA (21 CFR Part 820) and ISO 13485 regulatory compliance.
- Experience in managing the full Software Development Life Cycle (SDLC).
- Experience with project management tools such as JIRA, Microsoft Project, or SAP.
- Experience in leading cross-functional teams in a regulated environment.
- Excellent verbal and written communication skills.
Responsibilities:
- Lead and deliver complex technical programs in regulated environments.
- Manage full project lifecycles from requirements gathering to closure.
- Ensure continuous compliance with evolving regulatory requirements.
- Drive digital transformation initiatives or large-scale IT system integrations.
- Prepare for and support internal/external audits and regulatory inspections.
- Implement robust change management frameworks and foster a culture of quality.
- Build consensus and influence diverse cross-functional teams without direct authority.
Founded in 1999, Resourcesoft, Inc. is a leading Technology Consulting and Professional Services organization. Headquartered in Marlborough, MA, the company serves the technology needs of its clients nationwide. Resourcesoft has often been recognized by prominent rating agencies for its exemplary growth and stability. With over two decades of industry experience, the Company has evolved as a front runner in enabling project optimization. We partner with leading organizations to provide technology solutions within the financial, insurance, education, government, publishing, healthcare and pharmaceutical domains. We take pride in mentoring a workforce that is well positioned to respond to the emerging IT trends and needs. With the employees at the crux of every business endeavor, our success is driven by our expertise in pairing the right talent with the best jobs in the technology sector. We forge long term, personalized relationships with our employees to advance their career to the next level. We engage them in technology centric client projects that provide opportunities for them to evolve, innovate and deliver world class products and services. Our career opportunities offer challenging assignments and exposure to emerging and cutting edge technologies. We are committed to providing our employees with the tools necessary to accelerate their career progression, while maintaining a healthy, work-life balance. We are deeply committed to providing a workplace ambience that is both challenging and fulfilling.
Resourcesoft is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
For more information about Resourcesoft and our services, please visit our website.
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