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.
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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
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