Director, Regulatory Affairs (m/w/d)
QIAGEN GmbH - Germany
Berufsfelder
Verfügbarkeit
- Vollzeit
- ab sofort
Kurzbeschreibung
Director, Regulatory Affairs (m/f/d) Job ID: US/CA00849
At the heart of QIAGEN’s business is a vision to make improvements in life possible.
Join us. At QIAGEN, you make a difference every day.
Position Description
- Direct global in vitro diagnostic (IVD) product strategies for development, submissions, registrations, and maintenance of diagnostic instrument and software related 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.
- Support project and product teams to prioritize and identify issues that may increase regulatory risks and propose strategies to address such risks.
- 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.
- Lead and or participate in communications, and meetings, with Regulatory Authorities.
Unsere Erwartungen - Deine Fähigkeiten
Position Requirements- The ideal candidate will have 6-8 years of experience in regulatory affairs, including minimum 3 years in a team leadership role, for IVD companies, including successful pre-market submissions.
- Extensive knowledge of requirements and processes for US regulatory approval of IVD medical devices (ex-US knowledge is a plus). RAC preferred.
- Strong knowledge in IVD 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.
Unser Versprechen - Deine Vorteile
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.