• Regulatory and Quality Affairs Specialist

    Danaher CorporationBuffalo Grove, IL 60089

    Job #1578137238

  • Leica Microsystems has helped shape the future for over 170 years, by developing groundbreaking optical and digital solutions. As a global leader, we're driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus, innovation, and teamwork are at the core of our culture and the foundation of our success.

    Want to be part of a company whose products are part of cutting-edge research around the world? Join Leica Microsystems in our commitment for brilliant solutions and insight.

    Leica Microsystems is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

    The Regulatory & Quality Affairs Specialist will provide regulatory affairs and quality assurance expertise for Leica Microsystems (LMS) in the United States and Canada. In partnership with the Senior Manager RA/QA - Americas, this position will provide support for the RA/QA department to ensure efficient and compliant business processes and environment. This is an office-based position which will allow some flexibility for working remotely at times.

    The associate will assist in the compliance of LMS with applicable governmental regulatory, corporate and divisional policies and procedures. This person in this role will be encouraged to maintain current knowledge of FDA, Health Canada, and European regulations, legislation, standard methodologies, and guidelines related to RA/QA.

    This role will involve planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS). It will ensure compliance to ISO standards, and other regulations as they pertain to the QMS. It will also be responsible for developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

    Professional Experience

    4-5 years' experience in a regulated Medical Device company.

    Regulatory Affairs/Quality Affairs background area is preferred but may consider scientific affairs or related area. Note: Higher education may compensate for years of experience.

    High attention to details and accuracy and strong organizational and communication skills.

    Education

    Bachelor's Degree (or equivalent); Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.

    Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

    Language

    English

    When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

    Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible.

    If you've ever wondered what's within you, there's no better time to find out.

    LI-LW1

    When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (~~~) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (~~~) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at ~~~ or ~~~ to request ~~~ you've ever wondered what's within you, there's no better time to find out.