Franklin Lakes New Jersey / United States

Roles and Responsibilities:

• Lead and coordinate gap analysis and implementation of new or updated standards, guidance's, and regulations.
  
• Represent RA and demonstrate leadership in Audits, CAPAs, and related compliance activities.
  
• Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to partners.
  
• Proactively lead regulatory efforts required to align with new regulations and requirements; i.
  e.
  , EU MDR, MDSAP.
  
• Review protocols and reports to assure collection of appropriate data for regulatory submissions and regulatory compliance.
  
• Write and update standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards to support continuous product development and compliance efforts.
  
• Work cross-functionally and lead cross-functional teams to in preparation of product submissions
• Represent company in relevant external trade organizations.
  
• Remain current on standards and regulations affecting products and keep the relevant team and supervisors informed about potential impact.
  
• Identify ways to improve the efficiency of current work process and execute them.
  

Requirements:

• Read, analyze, and interpret, and review scientific, technical, and regulatory literature and documents.
  
• Effectively communicate information to peers and all levels of management.
  
• Translate regulations and guidelines into terms that other functions can understand and apply.
  
• Define problems, collect data, establish facts, and draw valid conclusions; communicate the conclusions both verbally and in writing to a variety of audiences.
  
• Solve practical problems based on a variety of concrete variables in situations where only limited standardization exists.
  
• Excellent writing skills; both formatting as well as the development of a clear logic trail to develop conclusions based on an understanding of factual evidence.
  
• Strong influencing skills.
  Establishes process and provides expertise for a specific area.
  
• May supervise a staff of associates and managers.
  

Education:

• Bachelor's Degree, preferably Master's Degree in life sciences.
  

Qualifications:

• 7-8 years of strong Regulatory Affairs/Compliance experience in medical device company.
  
• Expertise and sound understanding of design control processes; FDA, global regulations and standards, and Quality Systems.
  
• Working knowledge of medical device stand-alone software, device interoperability, IEC 62304 software development lifecycle, and IEC 60601
• Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information.
  
• Excellent interpersonal, communication and analytical skills.
  
• Knowledge of software and instrument design regulations and standards.