Regulatory Affairs Medical Writer

EXALTA Group; Bethlehem (Northampton County); On-site; USD 110,000 - 150,000; Full time

Job summary

EXALTA Group is seeking an experienced Medical Writer/Regulatory Affairs Specialist to lead CERs, PSURs, and SSCPs for our orthopedic device portfolio, including implants and surgical instrumentation.

This role ensures EU MDR compliance and supports regulatory strategy for joint reconstruction, spine, trauma, and extremities products. You will collaborate with Clinical, Product Development, Regulatory, Quality, and Post‑Market teams to deliver high‑quality documentation.

Qualifications

• Bachelor’s or advanced degree in Life Sciences, Biomedical Engineering, Pharmacy, or related field.
• 5+ years in medical writing, clinical evaluation, or regulatory affairs within medical devices.
• Direct experience authoring CERs, PSURs, and SSCPs; strong orthopedic device knowledge.
• Solid understanding of EU MDR, MEDDEV 2.7/1 Rev. 4, and MDCG guidance documents.

Responsibilities

• Author, update, and maintain CERs for orthopedic implants and instruments per EU MDR.
• Prepare PSURs per MDR for Class Ir–III devices and analyze PMS data for trends.
• Develop and maintain SSCP documents and translate complex safety information for patients.
• Collaborate with Clinical, Regulatory, Quality, and PM teams; support audits and submissions.

Skills

Medical writing

Regulatory affairs

Clinical evaluation

Orthopedic devices

Literature reviews

PSURs

SSCPs

EU MDR knowledge

ISO standards

Data interpretation

MS Office

Education

Life sciences / biomedical engineering / pharmacy degree

Job description

We are seeking an experienced Medical Writer / Regulatory Affairs Specialist to lead the preparation and maintenance of Clinical Evaluation Reports (CERs), Periodic Safety Update Reports (PSURs), and Summary of Safety and Clinical Performance (SSCPs) for our orthopedic device portfolio, including implants and surgical instrumentation.

This role is critical to ensuring compliance with EU MDR (2017/745) and supporting the clinical and regulatory strategy for joint reconstruction, spine, trauma, and/or extremities products.

This role will collaborate cross‑functionally with Clinical, Product Development, Regulatory, Quality, and Post‑Market Surveillance teams to ensure high‑quality documentation supporting product safety, performance, and regulatory compliance throughout the product lifecycle.

Key Responsibilities

Clinical Evaluation Documentation

• Author, update, and maintain Clinical Evaluation Reports (CERs) for orthopedic implants and instruments in accordance with EU MDR and MEDDEV 2.7/1 Rev. 4.
• Perform systematic literature reviews, clinical data appraisal, and benefit-risk analyses.
• Ensure clinical evidence supports device safety and performance claims.

Post‑Market Surveillance & Safety Reporting

• Prepare and maintain Periodic Safety Update Reports (PSURs) per MDR requirements for Class Ir, IIa, IIb, and III orthopedic devices.
• Analyze post‑market data including complaints, vigilance, and PMS data to identify trends.
• Contribute to signal detection, risk assessment, and updates to risk management files.

SSCP Development

• Prepare and maintain Summary of Safety and Clinical Performance (SSCP) documents for implantable and Class III orthopedic devices.
• Translate complex clinical and safety information into clear, patient‑friendly summaries.
• Interface with Notified Bodies for SSCP review, approval, and EUDAMED submission readiness.

Cross‑Functional Collaboration

• Collaborate with Clinical Affairs, Product Development, Quality, Regulatory Affairs, and Post‑Market Surveillance teams to gather necessary inputs.
• Ensure alignment between CERs, Risk Management Files, PMS reports, and labeling.
• Support internal and external audits, including Notified Body inspections.
• Contribute to regulatory submissions and lifecycle management activities.

Qualifications

Education

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

Experience

• 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 (e.g., joint replacement, trauma, spine, sports medicine) strongly preferred.
• Strong understanding of EU MDR (2017/745).
• Strong understanding of MEDDEV 2.7/1 Rev. 4.
• Strong understanding of MDCG guidance documents.
• Strong understanding of ISO 14155, ISO 14971, ISO13485 (preferred).
• Detail‑oriented with strong organizational skills.
• Ability to manage multiple complex products and deadlines.
• Excellent scientific writing, editing, and critical appraisal skills.
• Strong analytical ability to interpret clinical and safety data.
• Knowledge of literature search methodologies and databases (e.g., PubMed, Embase).
• Attention to detail and ability to manage multiple projects simultaneously.
• Strong communication and stakeholder management skills.
• Proficiency in MS Office and document management systems.

Preferred Qualifications

• Experience working with Notified Bodies and regulatory submissions in Europe.
• Familiarity with global regulatory frameworks (FDA, Health Canada, etc.).
• Experience in specific therapeutic areas (e.g., cardiovascular, orthopedics, diagnostics).
• Hybrid, or office‑based position.

EXALTA is an Equal Opportunity Employer. We respect every employee as an individual, and we hire and promote based on qualifications, performance, and potential — without regard to race, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.