Senior Director, Head of Regulatory Science
Location
Germantown, MD | United States
Job description
Overview
At the heart of QIAGEN's business is a vision to make improvements in life possible.
We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees - more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.
Join us. At QIAGEN, you make a difference every day.
Position Description The Senior Director, Head of Regulatory Science will report to the VP, Head of Global Regulatory Affairs and will lead a global team of highly experienced regulatory professionals with business-focused regulatory affairs responsibility. The position will be responsible for the support and continuous improvement of QIAGEN's Regulatory Science and intelligence functions helping to make improvements in life possible.
The Senior Director, Head of Regulatory Science will provide leadership to the QIAGEN Global Regulatory Science Team with a focus on driving analysis, influencing, and the adoption of new/changing regulations & standards. They lead and inspire the team to develop and deliver on competitive and innovative regulatory strategies and regulatory milestones, including an assessment of risks and mitigations, emerging data, and the probability of success of individual submissions.
The position will also serve as a strategic partner to QIAGEN business leaders and enable goal achievement by providing valuable insights and creative regulatory affairs solutions.
The position is to be based in QIAGEN America Headquarters in Germantown, Maryland.
Primary Responsibilities - Collaborate with cross-functional teams, including R&D, Quality Assurance, Clinical and Medical Affairs, and Marketing, to ensure regulatory requirements and strategy are considered in product development, including verification and validation activities, risk management, and throughout the product lifecycle.
- Direct the preparation and submission of high-quality regulatory filings, including premarket notifications, premarket approval applications, technical documentation summaries, and medical device license applications, to the US FDA, EU Notified Bodies, and Health Canada, and provide support for other global regulatory filings.
- Interact and negotiate with regulatory agencies during regulatory submissions, audits/ inspections, and other interactions to ensure successful outcomes.
- Provide strategic regulatory advice and manage internal processes to ensure effective communication across QIAGEN Business Areas regarding relevant policy, new or changing regulations, standards and standards related intelligence, trends, and changes.
- Support and evolve processes for regulatory intelligence to monitor and analyze regulatory changes, assessing the impact on the company's products and projects, and communicating relevant updates to internal stakeholders.
- Establish and maintain relationships with key regulatory authorities and participate in industry associations to stay informed about the evolving regulatory landscape and industry trends.
- Support other QIAGEN functions in partner and customer facing issues involving Regulatory Affairs aspects.
- Drive continuous improvement and consistency of regulatory science processes and guidance across business areas served.
- Lead and manage a team of regulatory professionals, providing guidance, coaching, and mentorship to foster their professional development and ensure business and departmental objectives are met.
- Strong leadership and management skills, with experience leading and developing high-performing teams
Position Requirements - A degree in a scientific or technical discipline is required; MS or PhD desirable.
- The ideal candidate will have a minimum 10 years of experience in regulatory affairs, with at least 5 years in a leadership role, for in vitro diagnostic (IVD) companies.
- Deep knowledge of regulatory requirements for IVD products, including FDA regulations (e.g., 510(k), PMA), EU IVDR, and other relevant international regulations.
- Strategic experience and ability, having demonstrated success related to the development and implementation of regulatory strategies for IVD products, ensuring compliance to all applicable regulations.
- Success in problem solving and developing risk-based solutions, with the capacity to navigate complex regulatory landscapes.
- Proven track record for successful regulatory submissions and clearances/approvals for IVD products; experience with companion diagnostics is a plus.
- Understanding of global regulatory, government affairs, and legal liability issues, FDA QSR, and ISO 13485 required.
- Demonstrated experience and acumen in interfacing with and working with 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 across all levels within QIAGEN.
- Ability to work well cross-functionally, and in team settings and independently, take a stand and ensure completion of time-critical projects.
- Strategic thinker, with ability to 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 identify and focus on the key priorities.
- Self-starting, self-reliant, courage of conviction.
- Passionate leader, enthusiastic and able to inspire others to drive results while helping team members feel competent, challenged, and supported.
- Strong communicator and influencer who is able to foster a trusted and collaborative relationship between Regulatory Affairs team and the business through diplomatic communication style.
- Unimpeachable ethics and a commitment to uncompromising integrity, known as a QIAGEN culture carrier.
- Passionate in driving Diversity and Inclusion.
QIAGEN requires proof of full COVID-19 vaccination as a condition of employment for new hires in all U.S. states other than Montana effective as of September 1, 2021. New hires and candidates will be required to present proof of full COVID-19 vaccination within three business days of start date or upon entry into the office (i.e., for interviews), whichever comes first. QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs. Candidates who require accommodation should contact
[email protected] . This policy is part of QIAGEN's ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community.
What we offer At 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, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person's appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.
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