Clinical Affairs Specialist

Haemonetics

Clinical Affairs Specialist supporting execution of clinical studies for medical device development. Collaborating with internal and external stakeholders to ensure compliance and high-quality clinical evidence generation.

Posted 7/9/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesJuniorMid-Level💰 $68,200 - $116,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical study support, including planning, execution, and regulatory compliance. Proficient in managing documentation, data quality, and collaboration with stakeholders in clinical research environments.

Highest-signal resume keywords

Clinical Study SupportGCP ComplianceRegulatory AffairsData ManagementVendor Coordination

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchRegulatory SubmissionsData AnalysisDocumentation MaintenanceStudy PlanningIssue ResolutionProtocol DevelopmentOperational DocumentationAudit ReadinessTMF Maintenance

Soft Skills

Organizational SkillsProblem-Solving SkillsCommunication SkillsAttention to DetailTime Management

Industry Keywords

Clinical AffairsMedical Device IndustryICH GuidelinesFDA RegulationsISO 14155IRB SubmissionsIDEPMA510(k)EU MDR

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support day-to-day activities for one or more company sponsored clinical studies from planning and start-up through reporting and close-out under the direction of project leadership
Support development and maintenance of study plans, timelines, trackers, and operational documentation
Track study activities, site communications, and assigned deliverables to support execution against project timelines
Collaborate with internal stakeholders, CROs, vendors, and clinical sites to support study execution and ensure assigned activities are completed in accordance with protocols and applicable regulations (e.g., GCP, FDA, ISO 14155)
Support site and vendor interactions, including coordination of study materials, communications, follow-up items, and documentation needs
Escalate operational issues, delays, or risks to project leadership as appropriate
Maintain proper study documentation, including TMF maintenance
Draft and review key clinical documents such as ICFs, CRFs, tracking logs, operational plans, study plans, and IRB submissions
Support data review, data cleaning, query follow-up, reconciliation, and issue resolution activities in collaboration with data management, CROs, and study teams
Identify data discrepancies, protocol deviations, and documentation gaps and escalate issues appropriately
Support study and clinical regulatory activities including participation in study design, data review, protocol and report development, and contribution to clinical sections of regulatory submissions (e.g., IDE, PMA, 510(k), EU MDR)
Support audit and inspection readiness activities, including document preparation, follow-up, and resolution of assigned action items
Update company SOPs, templates, and protocols/reports for clinical requirements

Requirements

What you’ll need

Bachelor’s degree in life sciences or related field
2+ years of experience in clinical affairs, clinical research, regulatory affairs, or a related field, preferably in the medical device industry
Strong understanding of GCP, ICH guidelines, and applicable regulatory requirements
Experience working with vendors, sites, and cross-functional teams
Excellent organizational, problem-solving, and communication skills
Ability to manage multiple priorities in a fast-paced environment
Strong attention to detail with emphasis on data quality, documentation accuracy, and reporting consistency
Basic understanding of clinical data analysis and issue resolution

Benefits

Comp & perks

Health insurance
401(k) with up to a 6% employer match and no vesting period
Employee stock purchase plan
Flexible time off for salaried employees
Accrual of three to five weeks’ vacation annually for hourly employees (based on tenure)
Accrual of up to 64 hours (annually) of paid sick time
Paid and/or floating holidays
Parental leave
Short- and long-term disability insurance
Tuition reimbursement
Health and welfare benefits