Associate Director/ Director, Regulatory Affairs - PCR Core Labs

Company: QIAGEN Gruppe
Location: Ann Arbor
Posted on: June 25, 2022

Job Description:

Associate Director/ Director, Regulatory Affairs - PCR Core Labs Apply online 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 5000 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

• Develop and implement global regulatory strategies for development, submission, registration, and maintenance of in vitro diagnostic (IVD) products.
• Lead submissions, communications, and meetings with Regulatory Authorities.
• Support Franchise to prioritize and identify issues that may increase regulatory risks and propose strategies to address such risks.
• 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.
• Direct solutions for complex topics regarding country specific regulations, guidelines, and precedents.
• Develop Regulatory Affairs processes and procedures for the Global organization.
• Support other QIAGEN functions with product issues involving Regulatory Affairs aspects. Position Requirements
  • The ideal candidate will have 6-10 years of experience in IVD regulatory affairs, including minimum 5 years in a team leadership role, responsible for successful pre-market submissions.
  • Extensive knowledge of regulatory requirements and processes for US, Canada, and EU commercialization of IVD medical devices (RoW knowledge is a plus). RAC preferred.
  • Strong knowledge in IVD medical devices, Instruments and Software
  • 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, registrations, complaint review for reportability, and generating/submitting agency reports (i.e., MDRs, Vigilance, etc.)
  • Understanding of global regulatory, government affairs, and legal liability issues, FDA QSR, 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, 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, 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 business challenges.
    • Structured and well organized.
    • Confident and out-going personality with excellent influencing skills.
    • Good business acumen, pragmatic and business oriented.
    • Able to identify and focus on the key priorities. 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 Benefits@QIAGEN.com . 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.

Keywords: QIAGEN Gruppe, Ann Arbor , Associate Director/ Director, Regulatory Affairs - PCR Core Labs, Executive , Ann Arbor, Michigan