Senior Regulatory Affairs Specialist
Dexter, MI

Job Responsibilities

• Prepare and support US and non-US product submissions such as 510(k), PMA, IDE, CE technical file and dossiers. Ensures compliance of submissions with all applicable regulations, guidance, and SOPs for regulatory submissions.
  
• Write and update SOPs, policies and work practices.
  
• Ensure Medical Device Technical Files are accurate and updated in compliance to requirements.
  
• Works closely with product development team to assure timeliness of product clearance and approvals.
  
• Assures that the product technical files are maintained with respect to state-of-the-art information including international standards.
  
• Support the implementation of clinical investigations and post-market activities.
  
• Review, approve and provide guidance for labeling and advertising of device products. 
  
• Participate in the risk management process and assure the Risk Management file is accurately maintained.
  
• Provide guidance on regulatory compliance issues related to US and International Quality Management Systems. 
  
• Interact with US and non-US government officials on product approval and compliance issues. 
  
• Responsible for assuring proper response to 3rd party audits and inspection findings.
  
• Leads Internal Audit Program.
  
• Maintain up-to-date knowledge of US and international regulations and guidelines (including risk management). Monitor external publication sources for issues applicable.
  
• Responsible for engineering change evaluation from regulatory perspective in order to determine when notifications and updates to the regulatory authorities are required.
  
• Implement required activities of post market reporting processes.
  
• Performs a broad variety of tasks in support of compliance as assigned by the department head.
  

Required Qualifications

• Bachelor’s Degree or higher in applicable science or engineering discipline or equivalent combination of education and relevant experience.   
  
• 4 years professional experience, minimum two year in either RA or QA in medical device industry.
  
• Working knowledge of US Quality System Regulations, EU Medical Device Regulations and ISO standards for medical devices required. Knowledge of worldwide regulations, guidelines and standard industry practices preferred.
  
• Exceptional analytical, problem solving & root-cause analysis skills.
  
• Strong regulatory aptitude ( i. e. able to read & comprehend regulations and technical documentation & execute procedures), 
  
• Excellent communication skills (written and oral) and very strong organizational skills.  Team player with demonstrated collaboration, negotiation & conflict resolution skills.
  
• Ability to multi-task & handle tasks with competing priorities effectively.
  
• Working knowledge and solid understanding of statistics.
  
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
  

Desired Qualifications

• Additional professional training desirable such as RAPs or ASQ certification or other scientific/technical training.
  

Travel Required

• Valid US driver’s license
  
• Travel expected both domestic and international – up to 10%
  

Travel Required

• Prolonged periods sitting at a desk and working on a computer.