Regulatory Affairs Clinical Specialist

Company Description

Welcony technologies support research labs, clinics, hospitals, and universities focusing on mental health, brain disorders, cognitive neuroscience, and neuromonitoring. Key brands include Magstim for Transcranial Magnetic Stimulation, MagstimEGI for High-Density EEG, Technomed for Clinical Neurophysiology, and Neurosign for Nerve Integrity Monitoring.

Role Description

Remote or Hybrid role based on location.

This job description applies to the Regulatory Affairs Clinical Specialist responsible for supporting clinical clinical evaluation indication and document remediation and maintenance requirements for medical device products.

The Regulatory Affairs Clinical Specialist is responsible for:

• Identifying and implementing regulatory strategies for clinical aspects and maintenance of medical device approvals and compliance.
• Authoring and maintaining Clinical Evaluation Plans (CEP), Literature Search Reports (LSR) and Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up (PMCF) actions as identified in the PMCF Plans, and authoring PMCF Reports accordingly for compliance maintenance
• Collaborating with clinical teams to ensure clinical trials and studies meet regulatory expectations.
• Providing clinical guidance for risk management review/surveillance activities for new product development/design changes/new indications for use.
• Ensuring compliance with regulatory requirements, including clinical investigation standards (e.g., ISO 14155, ICH-GCP).
• Reviewing and assessing clinical literature, safety data to support regulatory submissions.
• Supporting post-market surveillance activities, including adverse event risk assessments.
• Authoring regulatory documentation within the electronic quality management system (eQMS).
• Training internal teams on clinical regulatory requirements and industry best practices.
• Carrying out all responsibilities with minimal to no supervision and completing tasks in a timely manner, as required by the business.

Qualifications

MSc or PhD in Life Sciences, Biomedical Engineering, Medicine, or a related field is required.

Experience

• Minimum 4-7 years of experience in post-doctorate research, regulatory affairs or clinical affairs within the medical device industry.
• Strong experience with clinical evaluation reporting (CER) and post-market clinical follow-up (PMCF) documentation.
• Proven experience with FDA, EU MDR, UKCA, and Health Canada regulatory submissions.
• Familiarity with clinical trial design, Good Clinical Practice (GCP), and ISO 14155.

Skills & Competencies

• Strong technical writing skills, particularly in clinical documentation.
• Ability to analyze and interpret clinical data, using appropriate statistical methods and jsutifications.
• Excellent written and verbal communication skills.
• Strong project management and organizational skills.
• Ability to collaborate across cross-functional teams in a fast-paced environment.
• Detail-oriented with strong problem-solving capabilities.

Preferred Qualifications

• Experience with software as a medical device (SaMD) or combination products.
• Knowledge of global regulatory requirements beyond the U.S. and EU (e.g., China NMPA, Japan PMDA).
• Experience working with regulatory agencies and notified bodies.