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Sterilization Engineer III_US

Engineering
Remote
06 Months+

The Sterilization Engineer is responsible for intermediate activities related to the Development Services product and processes development, fabrication and sterilization of materials as work order needs dictate

EO Sterilization Validation (ISO 11135)
EO Residual testing (ISO 10993-7)
EO sterilization cycle optimization/development (ISO 11135)

Contract Specialist / Contract Manager

Business Support
Remote
12 Months+

We're seeking a detail-oriented Contract Standardization and Harmonization Specialist to review, organize, and propose practical business solutions and help us harmonize contracts and templates. Our aim is to clean up a database of 800+ contracts and reduce the amount to only those necessary with the goal of having to achieve a more efficient, streamlined contracting process. You will analyze consistencies and discrepancies among contracts and collaborate with the legal department and end users in harmonizing and reducing the total amount of contract templates utilized enterprise-wide. Project management experience is a must. Project Management: Oversee the implementation the contract templates clean-up process from initiation to completion

Contract Management
Project Management
Pharmaceutical Industry Experience
Legal/Law Background

Business Systems Analyst

Information Technology
Remote
6 months

Collaborates with business owners/stakeholder to understand business needs, processes project specifications, business case development, cost sheet analysis and data sources. Translates business needs into clearly defined and documented detailed, high-quality requirements, functional designs, and system supplemental specifications for new applications or analyzes change requests/enhancements in existing applications. Analyzes data to determine business problem, trends, or opportunities for process improvements. Responsible for testing and provides root cause analysis and corrective action plan. Responsible for verification that the delivered application requirements meet the customer needs based on the specifications, ensuring minimal defects in both UAT and production. Accountable for identification, documentation, and escalation of risks, defects and issues throughout the project lifecycle. Responsible for assisting in the resolution of risks, defects and issues. For smaller projects or initiatives may be accountable for project schedule and resource allocation up to and including matrix staff. Preferences : • Healthcare experience preferred • Dental experience preferred

Business System Analyst or BSA and Automation Testing or Automation or Testing Tools and SQL and DBA and Healthcare or Dental

IT Systems Analyst

Information Technology
Remote
6 months contract to hire

We are looking for a Versatile System Analyst with strong experience into EPIC modules preferred someone who is certified with EPIC willow inpatient looking for someone who comes from Healthcare background.

EPIC or EPIC Module or Epic Willow Inpatient and Systems administration or System Admin or IT System Analyst and Healthcare

Content Strategist & Writer

Business Support
Remote
4 Months + Possibilities of Extension

We are seeking a highly creative and detail-oriented Content Strategist & Writer to develop and execute engaging content strategies, primarily focused on establishing thought leadership and showcasing success through compelling case studies. This role blends strategic planning with hands-on content creation and meticulous editing across multiple platforms, ensuring all content aligns with our brand voice, target audience, and business goals. The ideal candidate is a versatile writer with a deep understanding of content marketing principles, specializing in thought leadership and case study development, while also possessing expertise in social and web content writing and strategy.

Content Management System or CMS and Content Creation or Content writing and Content Strategist or Content Strategy and Copyediting and Proof reading and Content Writer or Content Strategist

Medical Device Risk Management Consultant

Engineering
Remote
12 Months+

This is a Subject Matter Expert role in Risk Management within the Design Quality Assurance team. The role involves performing gap assessments, planning, organizing, executing, and reporting all usability and risk management activities through collaboration with cross functional teams. This role is responsible for support of EU MDR remediation projects of varying scope and complexity. This individual will collaborate with internal design and development, regulatory affairs, medical affairs, and manufacturing engineering partners.

RM SME position
experience with ISO14971:2019 is necessary
Working knowledge of ISO14971:2019
MDR requirements
and IEC62366-1:2015

Senior Regulatory Affairs Manager

Scientific
Remote
04 Months only

This role is to fill in for 4 months for a Clients’ Manager who is going on a Maternity leave. Minimum of 5 years of relevant experience Proven experience with regulatory submissions, including IND and CTAs Strong background in reviewing and editing regulatory affairs documents At least a Bachelor’s degree (with a heavy emphasis on hands-on experience) Additionally, the position will involve a panel interview as part of the selection process We are seeking a Manager, Global Regulatory Affairs, to work closely with the Global Regulatory Lead (GRL) for a given program(s).

Regulatory Submissions
including IND and CTAs
Reviewing and Editing RA documents
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