FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Senior Clinical Affairs Specialist
Establishment LabsSenior Clinical Affairs Specialist supporting clinical investigations and regulatory documentation for Establishment Labs’ medical-device and women’s-health products. Ensuring clinical evidence, compliance, and submissions meet international standards.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical documentation preparation and regulatory compliance, with a strong focus on EU MDR, ISO 14155, and GCP standards. Capable of providing clinical support for regulatory submissions and mentoring junior team members while ensuring data quality and compliance.
Highest-signal resume keywords
Clinical Documentation PreparationRegulatory Compliance (EU MDR, ISO 14155, GCP)Clinical Investigation SupportRisk Management PrinciplesBilingual Communication (Spanish and English)
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Evaluation Reports (CERs)Post-Market Clinical Follow-Up (PMCF) PlansSystematic Literature ReviewsClinical Data AnalysisMicrosoft Office Suite (Word, Excel, PowerPoint)
Soft Skills
Written CommunicationVerbal CommunicationMentoring
Industry Keywords
Medical Device RegulationsClinical AffairsEthics Committee SubmissionsDesign Quality AssurancePost-Market Surveillance
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead the preparation, review, and maintenance of clinical and technical documentation, including CERs, PMCF Plans and Reports, SSCPs, and related clinical documents
- Ensure clinical documentation complies with EU MDR, ISO 14155, GCP, MEDDEV guidance, and internal procedures
- Provide clinical and technical support for regulatory submissions, product registrations, certifications, and responses to regulatory authorities
- Support planning, execution, and oversight of clinical investigations, including study documentation and Ethics Committee submission packages
- Review clinical study documents, reports, literature evaluations, and clinical data analyses
- Monitor clinical data quality and study conduct, identify compliance issues, and support audit and oversight activities
- Serve as Clinical Affairs subject matter expert for Regulatory Affairs, R&D, Post-Market Surveillance, Design Quality Assurance, Medical Affairs, Commercial teams, and other stakeholders
- Support risk management activities with clinical input and alignment between clinical evidence and product safety requirements
- Mentor and provide technical guidance to junior Clinical Affairs team members
- Identify process improvements and enhance Clinical Affairs procedures, systems, and best practices
- Maintain current knowledge of regulations, clinical standards, scientific literature, and industry trends
Requirements
What you’ll need- Bachelor's degree in Health Sciences, Life Sciences, Nursing, Pharmacy, Medicine, Biomedical Engineering, or a related field
- 5 years of experience in similar roles focused on Clinical Investigation or Regulatory Affairs
- Strong knowledge of international medical device regulations and standards, including GCP and ISO 14155
- Experience conducting systematic literature reviews and evaluating clinical data and scientific evidence
- Knowledge of risk management principles in medical device development and lifecycle management
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Strong written and verbal communication skills in Spanish and English; intermediate to advanced English required
- Availability to travel as required
- Valid U.S. visa and Yellow Fever vaccination are desirable but not mandatory
Benefits
Comp & perks- 🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Establishment Labs Website LinkedIn All Job Openings 501 - 1000 employees Founded 2012 🏥 Healthcare 💼 Consulting 🍽️ Food & Beverage Healthcare
- Consulting
- Food & Beverage Establishment Labs is a global medical technology company committed to advancing women's health and wellness through innovative Femtech solutions. Specializing in breast health, aesthetics, and reconstruction, the company offers groundbreaking products like Motiva SmoothSilk breast implants and the Motiva Flora tissue expander. Their technologies are underpinned by scientific research and supported by an extensive portfolio of over 200 patent applications and numerous publications. Establishment Labs aims to normalize and democratize breast health through science-based innovations and evidence-based safety, striving to make a positive social, environmental, and economic impact with their solutions. Senior Clinical Affairs Specialist 🔥 3 minutes ago 🏢🏡 Coyol – Hybrid ⏰ Full Time 🟠 Senior ✨ Clinical Specialist 🗣️🇪🇸 Spanish Required Apply Now Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
- Lead the preparation, review, and maintenance of clinical and technical documentation, including CERs, PMCF Plans and Reports, SSCPs, and related clinical documents
- Ensure clinical documentation complies with EU MDR, ISO 14155, GCP, MEDDEV guidance, and internal procedures
- Provide clinical and technical support for regulatory submissions, product registrations, certifications, and responses to regulatory authorities
- Support planning, execution, and oversight of clinical investigations, including study documentation and Ethics Committee submission packages
- Review clinical study documents, reports, literature evaluations, and clinical data analyses
- Monitor clinical data quality and study conduct, identify compliance issues, and support audit and oversight activities
- Serve as Clinical Affairs subject matter expert for Regulatory Affairs, R&D, Post-Market Surveillance, Design Quality Assurance, Medical Affairs, Commercial teams, and other stakeholders
- Support risk management activities with clinical input and alignment between clinical evidence and product safety requirements
- Mentor and provide technical guidance to junior Clinical Affairs team members
- Identify process improvements and enhance Clinical Affairs procedures, systems, and best practices
- Maintain current knowledge of regulations, clinical standards, scientific literature, and industry trends 🎯 Requirements
- Bachelor's degree in Health Sciences, Life Sciences, Nursing, Pharmacy, Medicine, Biomedical Engineering, or a related field
- 5 years of experience in similar roles focused on Clinical Investigation or Regulatory Affairs
- Strong knowledge of international medical device regulations and standards, including GCP and ISO 14155
- Experience conducting systematic literature reviews and evaluating clinical data and scientific evidence
- Knowledge of risk management principles in medical device development and lifecycle management
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Strong written and verbal communication skills in Spanish and English; intermediate to advanced English required
- Availability to travel as required
- Valid U.S. visa and Yellow Fever vaccination are desirable but not mandatory Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates About us Is Remote Rocketship legit? Privacy policy Terms of service Job board SEO course Remote Job Search MasterClass AI Apply Copilot OpenClaw job finder Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs