Senior Specialist, Global Clinical Evaluation – MedTech Surgery

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Facilitate ongoing enhancements of Global Clinical Evaluation processes, encompassing literature review and documentation.

• Develop and present training programs for Global Clinical Evaluation and other departments.

• Organize and implement assigned Global Clinical Evaluation deliverables, which include protocols, reports, and regulatory communications.

• Guarantee the prompt delivery of high-quality documentation and uniform application throughout MedTech Surgery.

• Create and uphold procedures, templates, best practices, style standards, reference libraries, reviewer guidelines, and quality control instruments.

• Oversee the use and integration of systematic literature review platforms and statistical analysis tools.

• Identify stakeholders and establish communication frameworks.

• Coordinate internal and external Medical Writing resources, including vendors, reviewers, project managers, medical information specialists, and librarians.

• Foster the professional growth of internal resources.

• Collaborate with Global Clinical Evaluation teams and cross-functional stakeholders across Medical, Safety, Post Market Surveillance, Clinical Affairs, Design Quality, R&D, and Regulatory Affairs.

• Conduct technical reviews of data and reports to ensure scientific rigor, precision, and clarity in deliverables and regulatory submissions.

• Partner with vendors to implement scalable tools, automation, and AI-driven solutions where applicable.

• Monitor KPIs, track metrics, and report on improvement opportunities to leadership.

• Connect writing processes to relevant Quality Systems and Regulatory Processes.

• Assist in managing the Global Clinical Evaluation budget, updating resources, and approving invoices.

⛳️ Requirements

• BA/BS is required; advanced degree is preferred.

• 6+ years of experience in EU MDR, clinical evaluation reports, systematic literature reviews, or a closely related regulatory/clinical field.

• Knowledge and experience in narrative or systematic literature reviews, including PRISMA, Cochrane, and both qualitative and quantitative synthesis.

• Experience in scientific and medical writing.

• Familiarity with clinical research methodologies, common biostatistical methods, systematic reviews, clinical data appraisal, and medical writing.

• Preference for knowledge of global medical device regulations and guidelines.

• Expertise in change management is essential.

• Knowledge of automation/artificial intelligence opportunities in medical/technical writing is preferred.

• Experience with Regulatory/Notified Body front-room audits is preferred.

• Experience in mentoring medical/technical writers, managing high-volume project work, and overseeing internal and external writers/vendors is preferred.

• 20% domestic and international travel is required.

🏝️ Benefits

• Retirement plan (pension).

• Savings plan (401(k)).

• Long-term incentive program.

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year.

• Holiday pay, including Floating Holidays – 13 days per calendar year.

• Work, Personal and Family Time – up to 40 hours per calendar year.

• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.

• Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.

• Caregiver Leave – 80 hours in a 52-week rolling period.

• 10 days Volunteer Leave – 32 hours per calendar year.

• Military Spouse Time-Off – 80 hours per calendar year.