Regulatory Team Supervisor

Responsibilities

• Oversee the day-to-day operations and manage project workloads throughout the team.
• Provide regulatory guidance on IVDD, ensuring necessary compliance to both local and international requirements.
• Adapt and implement regulatory strategies dependant on requests and changes in requirements (eg. new standards and guidelines).
• Responsible for liaising with notified bodies and regulatory authorities.
• Communication and collaboration with other regulatory teams to support worldwide registrations and other wider projects requiring regulatory support.
• Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with global regulatory agencies.

Requirements

• The ideal candidate will have at least 3 years’ experience in Regulatory Affairs preparing EU Technical Documentation, preferably IVD experience.
• Possess a working knowledge of the IVDR, applicable ISO standards, knowledge of US medical device (IVD) regulations would also be an advantage.
• Demonstrated organisational, planning, and prioritising abilities, as well as strong technical writing ability.
• Experience in team management is a significant advantage.
• Strong written and verbal communication skills, both in English and German is essential.
• Demonstrated strong attention to detail; ability to work under pressure to meet deadlines.
• Ability to work on complex problems and exercise sound science-based decision making in developing regulatory strategies and solutions to regulatory problems.
• Must be articulate and able to communicate effectively with employees at all levels of the organisation on the telephone and in person as well as with key individuals outside the organisation, e.g. FDA reviewers, consultants.

Why apply?

• Opportunity to grow within a global business and gain knowledge from specialists across the Life Science industry.
• Working in a diverse and international team, driving the innovation and improvement of a global company.
• The flexibility to explore multiple career development pathways within the business.
• Be part of a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams.

Please submit your CV to us for a private and confidential discussion about the opportunity.