Global Clinical Regulatory Support Specialist

This is a fully remote position, open to applicants in Colorado.

📋 Description

• Create Clinical Evaluation Plans and Reports (CEPs/CERs) as well as Post-market Clinical Follow-up (PMCF) Plans and Reports.

• Gather, evaluate, and extract safety and performance data.

• Compile and author both new and scheduled Systematic Literature Reviews, Clinical Evaluation, and PMCF documentation.

• Oversee the development of CER and PMCF by coordinating with Clinical Safety, Quality Assurance, Regulatory Affairs, Clinical Affairs, research, marketing, engineering, and information specialists.

• Collaborate on systematic literature searches related to TBCT products, including equivalent, comparator, and competitor products.

• Review published literature to find relevant safety and performance evidence.

• Develop literature search strategies and assist in facilitating SLRs.

• Compile data on risk management, labeling, post-market surveillance, verification, validation, preclinical, and clinical aspects.

• Manage document reviews, resolve comments, and supervise the final approval process.

• Provide insights on risk management, clinical research, and literature evidence for product development.

• Conduct proactive literature reviews to spot complaints and safety issues.

• Represent the functional group during audits and contribute to global regulatory submissions or responses.

• Keep track of clinical evaluation and PMCF regulatory requirements.

• Formulate policies and procedures.

• Guide contractors in developing and updating documents.

• Share findings from clinical evaluations and proactive literature reviews.

• Develop timelines and draft reviews for SLR, Clinical Evaluation, and PMCF deliverables.

• Ensure adherence to relevant laws, regulations, standards, and company procedures.

⛳️ Requirements

• A graduate degree (e.g., MS, PhD) in a scientific, biological, medical science, or regulatory discipline, or equivalent education and experience necessary to perform essential functions.

• Minimum of 5 years of relevant experience.

• Proficient knowledge of research methodology and information management.

• Experience with pertinent databases.

• Familiarity with regulatory requirements.

• Training and experience in medical writing, systematic reviews, and clinical data appraisal.

• Experience in clinical evaluation reporting within academic, medical device or pharmaceutical industries, or device development roles.

• Understanding of clinical research and regulatory guidelines.

• Knowledge of CE Marking, IDE, PMA, 510(k), post-market/post-approval processes, GCP procedures, and legal compliance.

• Proficiency in Microsoft Office, including Excel, Word, and PowerPoint.

• Proven writing and critique abilities for clinical and regulatory documentation.

• Skills in program/project management.

• Capability to develop and implement global policies and procedures.

• Ability to analyze information from various internal and external sources.

• Willingness to learn general writing and presentation software.

🏝️ Benefits

• A variety of group medical, dental, and vision plans.

• Comprehensive wellness program.

• Coverage for life insurance and disability.

• Group accident, hospital indemnity, critical illness, and pet insurance options.

• 401(k) plan with matching contributions.

• Vacation and sick leave programs.

• Recognition, work-life balance, and well-being initiatives.

• Commitment to equal opportunity employment.

• Reasonable accommodations available for individuals with disabilities.

• A workplace that is tobacco-free and drug-free.