Welcony, Carmarthen, Wales, United Kingdom
Regulatory Affairs Clinical Specialist
Welcony, Carmarthen, Wales, United Kingdom
1 day ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Welcony Technologies supports research labs, clinics, hospitals, and universities focusing on mental health, brain disorders, cognitive neuroscience, and neuromonitoring. Key brands include Magstim for Transcranial Magnetic Stimulation, Magstim EGI 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 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), Clinical Evaluation Reports (CER), and Post-Market Clinical Follow-up (PMCF) actions as outlined 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, and new indications for use.
- Ensuring compliance with regulatory requirements, including clinical investigation standards (e.g., ISO 14155, ICH-GCP).
- Reviewing and assessing clinical literature and 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 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.
- Strong technical writing skills, particularly in clinical documentation.
- Ability to analyze and interpret clinical data using appropriate statistical methods and justifications.
- 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.
Seniority level
Employment type
Job function
Industries
- Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Welcony by 2x
Get notified about new Regulatory Affairs Specialist jobs in Carmarthen, Wales, United Kingdom.
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
:quality(80))
:quality(80))
:quality(80))