(Senior) Director – Regulatory Affairs (Companion Diagnostics)
Qiagen
- United Kingdom
- Permanent
- Full-time
- Extensive knowledge of IVD medical device regulatory requirements and submission processes for U.S. and E.U. (Rest of World (RoW) knowledge is a plus).
- Strong knowledge of companion diagnostic and device development processes is essential.
- Strategic experience and ability, having demonstrated success related to the development and implementation of pre-clinical and clinical strategies for clinical IVD products, implementation of regulatory systems, and assuring compliance to all applicable regulations.
- Proven track record of success in problem solving and developing risk-based solutions.
- Prior responsibility for FDA submissions including Q-submissions, IDE, PMA, and 510(k), complaint review for reportability, and generating/submitting agency reports (e.g., Annual Reports, etc.).
- Understanding of global regulatory issues, FDA QSR, IVDR and ISO 13485 required.
- Well-developed cross-functional project and team management skills.
- Strong leadership and demonstrated experience in interfacing and working with external partners and regulatory agencies, including FDA.Personal Requirements- Excellent verbal and written communications skills and the ability to convey complex regulatory requirements in a straightforward and practical manner.
- Passionate leader, enthusiastic and able to inspire others to drive results while helping members at all sites feel competent, challenged, and supported.
- A strong sense of ethics and a commitment to uncompromising integrity.
- Ability to work well cross-functionally, to work well in team settings and independently, to take a stand and ensure completion of time-critical projects.
- Strategic thinker, with ability to interpret and find novel solutions to complex regulatory and business challenges.
- Structured and well organized.
- Confident with excellent cross-functional influencing skills.
- Good business acumen, pragmatic and business oriented.
- Able to proactively identify and focus on the key priorities.
- 10% travel (willing to travel to Manchester, UK site).What we offerAt the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.[