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Sr. Manager, Regulatory Affairs - International


SUMMARY OF JOB:

Head of Regulatory Affairs Department in Germany.   Responsible for oversight, management, and development of regulatory staff. Execute regulatory initiatives to meet business objectives in compliance with global regulatory requirements and guidance’s.  

DUTIES AND RESPONSIBILITIES:

  • Provide supervision, coaching and development of Regulatory team members. 
  • Provide regulatory leadership to cross-functional product teams, develop global regulatory premarket and post-market strategies for navigation systems and accessories, single use and reusable surgical instruments. 
  • Develop and implement global regulatory strategies, oversee all aspects of regulatory submission development, and interface with health authorities.
  • Lead discussions with regulatory agencies (FDA, Notified Bodies etc.) to ensure approval of regulatory submissions. 
  • Manage distributors and RA consultants to ensure global registrations are completed on time and maintained.
  • Create and maintain regulatory affairs department procedures that comply with applicable domestic and international regulatory laws/standards and Company policies and procedures. Responsible for development of key regulatory processes that meet the business needs. 
  • Mentor, manage and develop direct reports. Train key personnel on regulatory policies, processes, and SOPs.
  • Determine submission and approval requirements in impacted geographies for new product registrations and post-market changes. 
  • Direct the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies. 
  • Maintain regulatory product release matrix to ensure only approved products are distributed to applicable geographies.
  • Provide strategic guidance on regulatory requirements to product development and operations teams. 
  • Ensuring compliance with the current regulatory procedures and updating the procedures when new regulatory requirements become effective (e.g. EU MDR).
  • Provide regulatory guidance to cross-functional teams including review of design control and quality system deliverables.
  • Advise the business of upcoming regulations and requirements and incorporate regulatory trends during regulatory strategy development.
  • Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation.
  • Provide regulatory support for quality assurance and regulatory compliance activities.
  • Maintain well-organized, auditable regulatory files.

EDUCATION AND EXPERIENCE REQUIREMENTS: :

  • Minimum of BS in life sciences, engineering, or equivalent required.
  • Minimum 8 years’ experience in regulatory affairs (medical device). 
  • Minimum of 5 years’ experience with US and EU Medical devices containing software.
  • Minimum of 5 years’ experience with regulation of capital equipment and reusable medical devices in the US and EU.
  • Proven track record of successful FDA, EU and ROW regulatory approvals and maintenance of regulatory approvals.
  • Must be fluent in German and English with excellent verbal and written communication skills.
  • Experience developing, implementing, and maintaining compliant regulatory processes.

OTHER QUALIFICATIONS:

  • Ability to work independently and as part of a team.
  • Ability to work with minimal supervision on multiple concurrent tasks/activities and meet corporate strategies and goals.
  • Excellent computer skills, knowledge of Microsoft Office package, SharePoint, MS Project, Excel, Windows, and e-mail systems.
  • Excellent verbal and written communication skills and the ability to work with all levels within the Company and regulatory agencies.
  • Strong organizational skills and attention to detail.
  • Enjoy working in a fast-paced startup environment with proven ability to be flexible and adaptable within a changing dynamic environment. 
  • Must be able to travel to US and other countries, as needed.
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