1. Provides scientific expertise throughout the development and publishing of clinical evaluation reports compliant to MDR 2017/745 with a thorough understanding of MEDDEV 2.7/1 Rev 4 guidelines.
2. Authoring Clinical documentation mainly the Clinical Evaluation Reports [CER] including clinical literature response writing to regulatory authority requests.
3. Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical Education, Complaints Team, Sales and Marketing, Quality Engineering and Risk Management, as well as internal reviewers & notified body).
4. Interact with internal teams to define, plan and strategize the development of Clinical Evaluation Reports for new products requiring CE mark and updating existing clinical evaluation reports for products already existing in the market.
5. Communicate new risk identified during clinical evaluation with marketing, product managers and regulatory teams and assist in updating labeling documents based on clinical evaluations.
6. Participate in post-market clinical safety and risk management programs as requested.
7. Acquire or possess in-depth knowledge of therapeutic areas (radiology, radio-diagnosis in cardiology, oncology, neurology and nuclear medicine), competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
8. Providing product guidance and expertise to the Clinical Affairs Associate to help with conducting literature searches on products/product families.
9. Critically appraise scientific literature and write clinical summaries for products.
10. Managing CER timelines as required by product development teams and global regulatory bodies along the product lifecycle.
11. Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.
12. Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented.
13. May assist with creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations and posters based on Intuitive clinical trials.
14. Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US, EU, Chinese, TGA guidelines, MEDDEV 2.7/1 Rev 4, MDR 2017/745)
15. Attention to detail and accuracy in capturing/reviewing clinical data
16. Work on cross functional teams with strong communication, presentation & interpersonal skills
17. Analytical thinking skills with strong demonstration of scientific writing and verbal communication.
Organization: Siemens Healthineers
Company: Siemens Healthcare Private Limited
Experience Level: Mid-level Professional
Job Type: Full-time