• Authors Clinical Evaluation Reports (CERs) including clinical section of regulatory authority requests.
• Maintains/updates existing company CERs according to internal SOPs.
• Lead internal team review and approval for Clinical Evaluation Reports.
• Communicates/collaborates with outside consultants in the development of CERs when necessary.
• Contributes toward post-market clinical safety and risk management programs as requested.
• Provides product guidance and expertise to the Clinical Affairs Associate to help with conducting literature searches on products/product families.
• Critically appraises scientific literature and writes summaries for articles, products and surgical procedures.
• Coordinates the efforts of cross-functional teams to produce scientifically accurate, high-quality technical documents.
• Remains current with regulatory requirements as they relate to clinical evaluations and clinical contributions to regulatory documents.
• Manages timelines and communication to ensure deliverables and milestones are met.
• Prepares for and participates in audits as needed.
• Interacts with internal and international teams (engineering/marketing/regulatory) to define the plan and strategy for development of the Clinical Evaluation Reports for new products requiring CE Mark.
• Acquires or possesses in-depth knowledge of competitor devices, state-of-the-art, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
• Conducts proofreading, editing, document formatting, review comment integration and document completion/approval activities.
• Assists with creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations and posters based on clinical needs.
• Ensures compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. GCP and US and OUS guidelines).
• Other duties as assigned

• Prepares basic statistical analysis reports as needed.
• Performs periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented.

This is a full-time position with typical business hours. It may reasonably require additional hours during the week and weekend; specific requirements will be determined with Manager. Occasional remote work may be allowed.

• Minimum of Masters Degree required
• Minimum of 5 years of medical writing experience.
• Experience with developing CERs per MEDDEV 2.7.1 Rev 4.
• Experience and skill performing medical literature searches (PubMed, Google Scholar, etc.)
• Excellent written communications skills- strong attention to detail related to consistency, grammar, syntax, and accuracy
• Ability to identify critical information needs and identify roles/individuals to involve for decision making within clinical evaluation assessment and report development
• Basic project/timeline management skills and organizational skills
• Ability to prioritize and manage multiple projects
• Self-starter attitude with ability to learn quickly and self-educate on different medical device products and procedures
• Strong familiarity with Microsoft Office