Senior Post Market Safety Specialist (Hybrid)

The incumbent delivers written documentation of safety assessments, supports the response to queries from regulatory agencies in relation to global vigilance reports (including U.S MDR filings), provides technical writing expertise and leadership to the generation of post market safety reports (such as PSUR and CSR), provides clinical/medical input to other post market surveillance activities, and serves on multifunctional teams. This individual will provide support to internal functional teams and groups, such as those responsible for complaint evaluation, reportability determination, complaint investigation, health hazard evaluation, risk file review, CAPA, and field actions.  

Responsibilities:  

• The incumbent will: 

• Provide professional support and guidance to the formally designated unit, such as in the areas of global vigilance reporting and technical compliance writing.  

• Interact with patients to obtain additional information and provide other support as part of critical complaint follow up. 

• Provide written responses to requests for a medical analysis of adverse events, potential or actual reportable events, and/or potential safety signals identified through data trending or complaint evaluation teams. 

• Lead and ensure on-time and effective completion of post market safety reports, such as PSUR and Canada Summary Reports, and collaborate with Clinical Affairs and Regulatory Affairs with respect to PMCF, SSCP, literature review, and clinical evaluation.  Provide support to these reports that includes an integrated qualitative and quantitative assessment of post market adverse events and interpretation of their medical significance with relevant recommendations. 

• Collaborate cross-functionally to write, compile, and/or provide expert input to compliance documentation for post market, such as device PMS plans, HHEs, CAPAs, and field actions. 

• Work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business and industry trends.  

• Acquire and maintain knowledge of assigned products/products and therapies including labeling, indications, populations evaluated, alternative therapies and treatments. 

• Partner with other members of RA/QA and provide medical input in the development of field action plans and safety communications; provide guidance to product issue investigation teams to identify events of interest. 

• Maintain knowledge of relevant regulations and guidelines in the medical device industry and the broader life sciences/healthcare/med tech ecosystem, including ISO 14971, FDA, MDCG, IMDRF, and ICH guidelines for classifying and reporting medical device and drug adverse events. 

• Contribute to the development and implementation of safety program initiatives, process, 

improvements, and sound safety principles and practices. 

 
 
Education and Experience: 
Minimum Requirements: 

• Minimum of 5 years’ experience in Quality Assurance, Regulatory Affairs, Medical Device engineering and development, Post Market Surveillance, and/or Medical/Clinical/Patient Safety in a medical technology, life sciences, or healthcare setting. 

• At least 3 years’ experience in professional writing in a medical technology, life sciences, or healthcare setting. 

• At least 3 years’ work experience specifically in clinical risk management or post market safety. 

• BA/BS degree in healthcare discipline, engineering