Regulatory Affairs Specialist - Medical Device

This is a remote position.

KP Recruiting Group is a consulting firm that provides leadership and exceptional talent to some of the world’s leading companies. Headquartered in the Midwest, KP Recruiting Group has successfully completed countless engagements across the United States. We represent clients in all industries and all sizes. Our mission is to provide exceptional client and candidate experiences in order to get the best possible results. On behalf of our client, we are excited to present the following confidential role. We look forward to hearing from you and discussing the opportunity!

The Role:

Position Summary 

This position is responsible for support of a variety of regulatory activities and projects, and/or personnel.  The primary focus of this position is assessing changes to commercialized product to determine the worldwide regulatory impact of the change, preparing documentation to support the regulatory pathway for the change, and communicating the change impact to affected organizations.  This position may provide Regulatory guidance to project teams, Operations, and/or Sales in relation to the changes.  This position requires staying abreast of global regulations to help MMS achieve its business goals within the scope of this position, contributes to regulatory affairs strategy development, and exhibits strong cross functional influencing skills.

Key responsibilities:

• Review, approve, and document regulatory changes to commercialized devices.   
  

• Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory changes to partners.
  

• Proactively lead regulatory efforts required to align with new regulations and requirements; i.e., EU MDR, MDSAP.
  

• Review changes and related documentation 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.
  

• Work cross-functionally across multiple departments to communicate change impact.
  

• Remain current on standards and regulations affecting products and communicate and incorporate required changes.
  

• Identify ways to improve the efficiency of current work process and implement them.
  

• Performs other duties and assignments as required.
  

Professional Skills & Key Competencies:

• 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. 
  

Requirements

• Bachelor’s degree required (Master’s degree in life sciences field preferred)
  

• Minimum 5 years of strong Regulatory Affairs experience in the medical device industry.
  

• Working knowledge of medical device stand-alone software, device interoperability and IEC 62304 software development lifecycle.
  

• Sound understanding of design control processes, FDA, and global regulations and standards.
  

• 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.
  

Desired/Additional Skills & Knowledge:

• Familiarity with infusion pumps, safety assurance cases, human factors, and cybersecurity.
  

Certifications:

• RAC desired.
  

Any Additional Information:

• REMOTE or San Diego, CA based
  

• If Remote - Ability to travel up to 30% (when travel is able to resume safely)
  

Benefits

• 401k Matching
  
• Family and Individual Insurance Packages (Health, Life, Dental, and Vision)
  
• Paid Time Off & Paid Holidays
  
• Long & Short-Term Disability
  
• Identity Theft Plans
  
• Retirement & Pension Plans
  
• Employee Assistance Program
  
• Employee Referral Program
  
• Tuition Reimbursement Programs
  
• Advancement & Professional Growth opportunities 
  
• Parental Leave
  
• & More