Orthopedic Regulatory Medical Writer (EU MDR Expert)

Tyber Medical LLC.; Bethlehem (Northampton County); On-site; USD 100,000 - 150,000; Full time

Job summary

Tyber Medical LLC. is seeking an experienced Regulatory Affairs Medical Writer to lead the creation and maintenance of CERs, PSURs, and SSCPs for our orthopedic portfolio.

You will ensure compliance with EU MDR and coordinate with Clinical, Product Development, Quality, and Post-Market Surveillance teams to support product safety and regulatory filings. The role emphasizes high-quality scientific writing, data interpretation, and collaboration with Notified Bodies for SSCP reviews, with a focus

Qualifications

• 5+ years in medical writing, clinical evaluation, or regulatory affairs within the medical device industry.
• Direct experience authoring CERs, PSURs, and SSCPs.
• Strong experience with orthopedic devices (joint replacement, spine, trauma, sports medicine) preferred.
• Knowledge of EU MDR (2017/745), MEDDEV 2.7/1 Rev. 4, MDCG guidance, ISO 14155/14971/13485 preferred.

Responsibilities

• Author, update, and maintain CERs for orthopedic implants and instruments per EU MDR and MEDDEV 2.7/1 Rev. 4.
• Prepare and maintain PSURs per MDR for orthopedic devices; analyze PMS data and risks.
• Develop SSCPs and translate clinical/safety information into patient-friendly summaries.
• Collaborate with Clinical Affairs, Product Development, Quality, Regulatory, and PM/Safety teams; support audits and regulatory submissions.

Skills

Medical Writing

Regulatory Affairs

Clinical Evaluation

PSURs

SSCPs

EU MDR

MEDDEV 2.7/1 Rev. 4

Notified Bodies

Regulatory Submissions

Lifecycle Management

Orthopedic Devices

MS Office

Education

Bachelor’s or advanced degree in Life Sciences, Biomedical Engineering, Pharmacy, or related field

Tools

MS Office

Document Management Systems

Job description

Tyber Medical LLC. is seeking an experienced Regulatory Affairs Medical Writer to lead the creation and maintenance of CERs, PSURs, and SSCPs for our orthopedic portfolio.

You will ensure compliance with EU MDR and coordinate with Clinical, Product Development, Quality, and Post-Market Surveillance teams to support product safety and regulatory filings. The role emphasizes high-quality scientific writing, data interpretation, and collaboration with Notified Bodies for SSCP reviews, with a focus