Senior Regulatory Affairs Manager

Position Responsibilities

• Participate on project development teams and represent regulatory affairs by supporting project and product teams.
• Prepare regulatory submissions as required for global approvals for in vitro diagnostic (IVD) products, including preparation of reports and interaction with regulatory officials as required.
• Prepare and submit to notified body Technical Documentation needed to demonstrate compliance with applicable European Regulations (IVDR, MDR).
• Prepare regulatory submissions for US (e.g. 510k, PMA) and Health Canada approvals for IVD products.
• 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.
• Interface with regulatory agencies for inquiries and issues.
• Support product change control process from a regulatory perspective and life-cycle management of product US annual reports and Health Canada Summary reports.

Position Requirements

• The ideal candidate will have 5 years of experience in a regulated industry, with at least 3 years’ experience in Regulatory Affairs preparing EU Technical Documentation, US FDA 510(k) and/or PMA submissions, preferably IVD experience.
• Possess a working knowledge of the IVDR, applicable ISO standards, and US medical device (IVD) regulation.
• Demonstrated organisational, planning, and prioritising abilities, as well as strong technical writing ability.
• 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.
• Flexibility to adjust to changes in schedule, priorities, product availability and perform multiple tasks simultaneously.

We offer:

– Possibility to develop in an international company
– Attractive pension
– Private Healthcare
– Private Dentalcare
– Gym membership contribution
– Access to an Employee Assistance Programme
– A range of retail discounts and offers

– Opportunity to join internal QIAGEN communities

– Enhanced maternity package

– Flexible working options
– Bonus/commission
– 25 days annual leave (potential to increase linked to service)