Global Manager, Regulatory Affairs Operations - Regulatory Intelligence

Job Description

The Regulatory Global Operations Team Lead – Regulatory Intelligence is responsible for providing regulatory intelligence support, in relation to the Olympus portfolio and the regulatory landscape (e.g., environmental / electrical regulations). The Lead will act as a point of contact / escalation for divisions and regions in obtaining and disseminating the intelligence obtained.

Job Duties

The Regulatory Operations Team Lead – Regulatory Intelligence will oversee their team in performing the following:

• 
  Perform regular monitoring of the regulatory environment, to identify potential Regulatory Intelligence which may impact Olympus’ product portfolio.

• 
  Aggregate identified Regulatory Intelligence and perform quality checks to confirm that information is accurate.

• 
  Perform impact assessments on intelligence provided, before sharing with other stakeholders (internal and external to Regulatory Affairs) to ensure Intelligence is relevant and it is clear how this will impact Olympus’ portfolio and operations.

• 
  Monitor the implementation status of new regulatory requirements based on Regulatory Intelligence.

• 
  Provide budgetary information to Sr. Global Manager, Regulatory Affairs Operations, to assist with budget setting and monitoring.

• 
  Partner with regional Regulatory Affairs functions to ensure new regulatory requirements are collected and analyzed.

• 
  Drive quality mindset to reinforce the corporate brand and become a trusted, collaborative and preferred business partner across Olympus.

• 
  Mentor, manage and develop direct reports.

• 
  Provide training to direct reports on regulatory policies, processes, and SOPs.

• 
  Monitor team KPIs to ensure efficiency and quality of tasks.

Job Requirements

REQUIRED QUALIFICATIONS:

• 
  Bachelor’s degree in Engineering, Non-Medical or Science (or similar) is required. Master’s degree preferred.

• 
  Experience in Regulatory Affairs (minimum 5 years) with specific management experience, ideally in a matrix organization.

• 
  Regulatory project management support experience, in particular covering regulatory intelligence, project management, submissions, and publications.

• 
  Experience supporting significant parts of the end-to-end product lifecycle management activities.

• 
  Experience authoring and or managing a range of global regulatory submissions (e.g., 510(k), CE Mark etc); Prepare regulatory submissions to support product commercialization (e.g., 510(k), CE Mark Technical File, International).

• 
  Experience managing and operating QMS processes and systems.

• 
  Experience of working globally with understanding of global process flows and teaming.

• 
  Travel will be required 10-20% of the time (both domestic and international).

PREFERRED QUALIFICATIONS:

• 
  Leadership and interpersonal skills to develop and manage good working relationships within Regulatory Affairs and with other internal departments (R&D, Manufacturing, Supply Chain, Quality etc).

• 
  Strong written and verbal communication skills.

• 
  Strong IT skills – experience utilizing a relevant regulatory system (desirable, e.g., RIM / PLM), QMS systems (essential) and basic Office applications (essential), including MS Office (Word, Excel, PowerPoint, Outlook, Teams)