Senior Regulatory Affairs Engineer

Senior Regulatory Affairs Engineer at Inspiration Healthcare

Job Purpose (Role Definition): Working within the Quality Assurance and Regulatory Affairs team, the Senior Regulatory Affairs Engineer assures regulatory requirements are met for new product introduction and design changes to established products. The role proactively supports the company in achieving regulatory goals and objectives, maintains necessary regulatory clearances, and delivers regulatory deliverables from internal R&D projects. It contributes to providing regulatory solutions to business requirements and changes to the regulatory landscape and provides operational regulatory input and guidance to cross‑functional teams, ensuring compliance with UK, European, and international legislation.

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• Ensure compliance with global regulatory requirements and company policies.
  
• Prepare documentation for the filing of regulatory submissions to the US FDA.
  
• Maintain compliance with regulations set by the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
  
• Maintain compliance with the EU Medical Device Regulation (MDR).
  
• Develop and maintain policies and procedures for data in the EUDAMED system and other international regulatory systems.
  
• Prepare submission packages for European agencies and other international authorities within required timelines.
  
• Plan, lead, and support regulatory efforts for new product launches.
  
• Keep up to date with changes in regulatory legislations and guidelines.
  
• Liaise and negotiate with regulatory authorities.
  
• Contribute to regulatory intelligence to produce and maintain applicable standards and processes.
  
• Act as the point of contact for regulatory support across business functions.
  
• Establish and maintain regulatory information systems such as technical documentation and routine reports.
  
• Drive understanding of existing and new regulatory requirements, guidelines, and standards as they relate to company products and procedures.
  
• Take regulatory responsibility for the compliance lifecycle management of assigned products and projects.
  
• Perform regulatory review of business documentation (e.g., marketing material, design changes) and determine their impact on regulatory submissions.
  
• Assist and support inspections and audits.
  

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• Degree in sciences, life sciences, engineering, or quality management, or equivalent education gained through work experience.
  
• Minimum of 3 years regulatory experience with Class II medical devices.
  
• Direct interaction with regulatory authorities.
  
• Experience working across export markets and dealing with international distributors.
  
• Familiarity with the EU Medical Device Directive and Medical Device Regulation.
  
• Experience with quality system concepts, practices, and procedures (e.g., ISO 13485, MDSAP, CFR 820).
  
• Problem‑solving mindset; proactive and solutions‑oriented.
  

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• Knowledge of ISO 14971, BS EN 60601, IEC 62366 and IEC 62304.
  
• Experience with project management.
  
• Experienced interaction with regulatory agencies.
  
• Continuous improvement mindset.
  

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• Ability to work as part of a team and across multi‑disciplinary teams on projects.
  
• Maintain assertiveness and integrity under pressure.
  
• Ability to interpret, adapt, and implement product regulations.
  
• Strong written and verbal communication skills.
  
• Computer skills (MS Office).
  
• Qualitative and quantitative analytical skills.
  
• Clean driving record and willingness to travel as required.
  
• Fluent in English.
  
• Effective time management.