Company Overview:
Candela Corporation is a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint. We are the market leader in the development, and distribution of medical and aesthetic laser and light-based technologies. The Company’s technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic application including hair removal, wrinkle reduction, tattoo removal, improving the skin’s appearance through the treatment of benign vascular and pigmented lesions, and the treatment of acne, leg veins and other common indications.
The Company is headquartered in Marlborough, Massachusetts, USA, with an additional R&D facility in Yokneam, Israel and commercial locations across Asia Pacific, and Europe. Products are sold directly in 18 countries worldwide and are supported by capital sales, field service, clinical education, technical support and marketing development organizations. Candela maintains contracted distributors in over 60 other countries.
General Summary
The Global Clinical Evidence Specialist will support the development and creation of Clinical, Scientific, and Regulatory documents in accordance with EU MDR, US FDA, and other global requirements. This includes assisting with, writing, and reviewing Clinical Evaluation Reports CERs), Post Market Clinical Follow-up Reports (PMCFRs), analysis of clinical safety and performance data, creation of Clinical Study Reports, conducting literature reviews, collecting and analyzing feedback from various sources to support the CER and PMCFR and various global clinical evidence needs. The Global Clinical Evidence Specialist may also contribute to or author other technical documents that support Clinical, Regulatory, Risk Management, or Post-Market Surveillance (PMS) efforts (e.g., Clinical Evidence Strategies, Benefit-Risk Determinations, etc.)
Primary Responsibilities
· Ensure Clinical Evaluation Reports (CERs) are appropriately integrated with Quality Management System (QMS), Regulatory, Risk Management, and Post-Market Surveillance (PMS) documentation to maintain consistency, traceability, and accessibility
· Lead comprehensive literature reviews, synthesize scientific evidence, develop clinical evidence reports, conduct cross-functional evidence gap analyses, and recommend strategic evidence-generation approaches
· Establish and maintain a centralized library of peer-reviewed literature and internal scientific publications
· Design survey methodologies, oversee distribution, data collection, and clinical data analysis to support evidence generation and PMCF activities
· Identify and escalate complaints, adverse events, and potential off-label use identified through literature reviews and PMCF surveys to the PMS group in accordance with applicable SOPs
· Support and maintain EUDAMED entries related to clinical affairs deliverables, ensuring accuracy and compliance
· Maintain in-depth knowledge of company products, competitive technologies, state-of-the-art advancements, clinical and market trends, and applicable regulatory requirements
· Collaborate with external consultants and cross-functional teams to develop, review, and finalize CERs, LSRs, PMCFRs, CSRs, and related clinical documentation
· Develop Clinical Investigation Protocols and Clinical Study Reports in partnership with Clinical Operations, Engineering, Quality Assurance, Regulatory Affairs, and Marketing teams as appropriate
· Lead the development, review, and submission of scientific abstracts and manuscripts; manage journal submissions and coordinate responses to peer reviewer feedback
· Provide support during audits and regulatory inspections related to clinical affairs activities
· Manage timelines and stakeholder communication to ensure timely delivery of milestones, while adhering to Good Documentation Practices (GDP) and Product Lifecycle Management (PLM) requirements to ensure document quality and compliance
Knowledge/Educational Requirements
· Bachelor’s degree (B.S./B.A.) or equivalent combination of education and relevant industry experience
· Minimum of 5 years of clinical trial experience within the medical device industry or a related regulated industry
· Strong computer proficiency, including Microsoft Office (Word, Excel, Teams), Adobe, and SharePoint
· Preferred experience with data management tools and systems, including survey, administrative, and clinical investigation data; reference management software (e.g., EndNote, Zotero, Mendeley); and clinical research databases (e.g., PubMed, Embase, Cochrane, ClinicalTrials.gov, Google Scholar)
· Working knowledge of global regulatory guidelines and requirements, including U.S. FDA regulations (21 CFR Parts 56 and 812), ISO standards, Good Clinical Practice (GCP), and European Union Medical Device Regulations (MDR)
· Demonstrated ability to prioritize and manage multiple tasks effectively through strong organizational and time management skills
· Strong communication skills with the ability to interact effectively across multiple organizational levels and with external stakeholders
Essential Job Requirements:
· Adherence to all relevant current policies, procedures, and guidelines related to this position
· Maintenance of knowledge base required to perform the Essential Job Functions of this position.
· Training of Clinical Evaluation Process to the current requirements of the EU Commission Regulation No. 2017/745 Medical Device Regulation (MDR), and future revisions.
Salary Range: $110-120k.
This job description is not all inclusive and is intended to capture a majority of the job functions. Special projects and other tasks may be required by management.