Sr. Regulatory And Clinical Affairs Specialist - Medication Delivery - Remote - 1439325

Our client is leading the path forward on medication delivery. As the Senior Regulatory and Clinical Affairs Specialist, you will have the opportunity to work on a global scale, interacting with international regulatory agencies, and supporting regulatory compliance internally. This is a great opportunity for someone with Class II device experience looking to broaden their portfolio on the international market.  

Requirements:  

• Bachelor’s degree required; technical degree preferred.  
• 5+ years of experience in regulatory affairs in the medical device industry, including experience in Class II devices. 
• Minimum 2+ years of medical or technical writing experience. 
• Experience working with both domestic and international regulatory agencies, including obtaining and maintaining CE Markings.  
• Robust knowledge of Medical Device Quality Systems such as: FDA 21 CFR 820, ISO 13485, MDSAP, EU MDR 
• Expert knowledge of all product lifecycle processes.  

Responsibilities:  

• Work directly with regulatory agencies with the support of leadership. 
• Help lead EU MDR transition initiatives.  
• Assist in the review of product labels and promotional materials to ensure compliance with regulations and standards. 
• Maintain regulatory files including authorizations such as 510(k)s, Canadian medical device licenses, and CE technical files for EU. Ensure that all needed registrations and renewals are completed in a timely manner. 
• Develop regulatory strategies and implementation plans for products, preparing submissions for the U.S. market, Europe, and other major global markets. 
• Analyze and evaluate clinical evidence from all sources including clinical investigations and literature, post-market surveillance and more. 

Compensation: $150,000-$165,000 base, plus bonus 

Travel: Minimal 

Years of Experience: 5+ years in regulatory affairs in medical device 

Degree: BA/BS 

Location: Remote

This job description is not intended to be all-inclusive and may have been abbreviated or maximized for online or mobile viewing. Employees may perform other related duties as negotiated to meet the ongoing needs of the organization. 

Legacy MedSearch was named to the 2019, 2020, 2021, 2022, and 2023 Forbes list of Best Recruiting Firms in America.