Remote Senior Technical Writer, Medical Devices (CER/SSCP)

Vita Global Sciences, a Kelly Company; New Brunswick (NJ); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical benefits

Paid time off

401K

Job summary

Kelly Science and Clinical FSP is seeking a Technical Writer to support our Medical Device client in a remote, full-time role. You will oversee CER and SSCP documentation, mentor junior writers, and ensure regulatory compliance across clinical evaluations.

Ideal candidates have a BA/BS/BSN with advanced degree preferred, and strong communication and regulatory knowledge in medical devices. Benefit options and PTO are provided.

Qualifications

• Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and CER document creation
• Strong verbal communication skills and interpersonal relationships
• Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting, medical device risk management process, and common statistical methods is preferred

Responsibilities

• Plan and write CERs and SSCPs and mentor junior technical writers.
• Conduct technical reviews to ensure document accuracy and regulatory compliance.
• Partner with team members to address needs of each contributor.
• Manage daily activities to ensure timelines are met.
• Participate in workshops and initiatives to improve process efficiency.
• Participate in continuous education to improve understanding of regulatory requirements and industry trends/practices.
• Support and, at times, act as SME during audits and inspections pertaining to processes and reports.
• Communicate business issues or opportunities to management.
• Ensure subordinates follow all guidelines related to Health, Safety and Environmental practices and that resources are available and in good condition.

Skills

CER regulatory knowledge

Verbal communication

Interpersonal skills

Clinical research knowledge

Regulatory compliance awareness

Education

BA/BS/BSN required

Advanced degree preferred

Job description

Kelly Science and Clinical FSP is seeking a Technical Writer to support our Medical Device client in a remote, full-time role. You will oversee CER and SSCP documentation, mentor junior writers, and ensure regulatory compliance across clinical evaluations.

Ideal candidates have a BA/BS/BSN with advanced degree preferred, and strong communication and regulatory knowledge in medical devices. Benefit options and PTO are provided.