The ideal candidate will participate on project development teams and manage a small team of employees that oversee the product change control process from a regulatory perspective.
Prepare global regulatory strategies for in vitro diagnostic (IVD) products;
Direct and 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;
Participate on project development teams and represent regulatory affairs by supporting project and product teams to prioritize and identify issues that may increase regulatory risks and propose strategies to address such risks and review of documents;
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 and interface with regulatory agencies for inquiries and issues;
Develop regulatory process SOPs relevant for registration of IVD products or other regulatory aspects and oversee and support product change control process from a regulatory perspective and lifecycle management of product US annual reports and Health Canada Summary reports;
Supervise other employees as part of the team and support other QIAGEN functions with product issues involving Regulatory Affairs aspects.
The ideal candidate will have 5-8 years of experience in regulatory affairs, including minimum 3 years in a team leadership role, for IVD companies, including successful pre-market submissions;
Extensive experience in the medical device industry, preferably with IVD experience, and extensive regulatory experience, preferably in the area of IVDs, including the preparation and submission of 510(k), PMAs and CE Technical documentation Summaries under the EU Regulation;
Possess a working knowledge of the MDR and IVDR, applicable ISO standards, and US medical device (IVD) regulation;
Demonstrated organizational, planning, and prioritizing abilities, as well as strong technical writing ability;
Strong leadership and demonstrated experience in interfacing and working with external partners, regulatory agencies, including FDA;
Well-developed cross-functional project and team management skills;
Ability to work well cross-functionally, and in team settings and independently, take a stand and ensure completion of time-critical projects;
Excellent verbal and written English communications skills and the ability to convey complex regulatory requirements in a straightforward and practical manner.