This is a management position providing expertise and management of the Regulatory Affairs (RA) function for Leica Biosystems Core Histology Products based in Richmond, Illinois. Responsible for a broad spectrum of global regulatory needs, including pre-market and post-market regulatory affairs to support Leica’s growing business. Ensures RA deliverables are coordinated across multiple LBS global regulatory authorities working in a highly matrixed environment.
Responsibilities may include specialized responsibilities in adverse event reporting (MDR, Vigilance, HHE), registrations/submissions, compliance, device listing, communications with regulatory bodies, recalls and field actions, advertising & promotion, regulatory support of new product development and device change processes. The RA Manager is experienced in multiple areas of medical device regulatory affairs and is capable of applying that experience and in-depth knowledge to work independently with minimal mentorship from management. May lead small projects with manageable risks and resource requirements. tackle complex problems affecting site’s regulatory obligations. Shares information and experience across LBS and Danaher sites; may serve as representative on task-forces, councils or improvement initiatives.
Responsible for planning, prioritizing and conducting duties related to assigned areas of the site’s regulatory obligations: May include one or more of the following areas:
Per process, Review and approve labeling, advertising and promotion for compliance to applicable regulations
Familiar with progress of new and updated regulations that impact the business (regulatory intelligence, coordinated with Global Regulatory)
Implementation of new regulations in conjunction with Global Core Histology
Identify and implement new or updated regulations that are routine or do not have a major impact on the business. In conjunction with management, develop plans to implement regulations that have a significant impact on the business (e.g. IVDR, UDI, Companion and Complementary Diagnostics)
Participate and contribute to LBS or Danaher councils for regulatory intelligence and compliance
Submissions, registrations, device listings, site licenses
Work with global colleagues in support of product registrations and submissions.
Establish and maintain official site regulatory files according to government expectations and company procedures
Serve as site RA representative on new product development teams and change management initiatives
Establish and maintain device listings and licenses according to government requirements
Support the documentation of regulatory strategies
Utilize knowledge and experience to identify and tackle problems within the regulatory area.
Use Danaher Business System (DBS) tools on a regular basis to continually improve the RA function.
Establish and maintain strong relationships with internal and external partners.
Maintain working knowledge of relevant regulations and requirements that affect the business.
Other duties as assigned by management.
Required Education, Experience, Skills
Bachelor’s degree in science, medical or technical field
3+ years’ experience in IVD or Medical Device Regulatory Affairs
A minimum of 2 years leadership experience
Must have requisite training in medical device Regulatory Affairs through on-the-job training, seminars, training. Relevant certifications preferred.
Desired Education, Experience, Skills
Graduate, advanced degree preferred
Experience in the IVD field preferred
Ability to apply practical RA experience and knowledge to one or more area(s) of regulatory affairs
Ability to identify and assess patient and user risk
Strong organizational skills. Ability to multitask
Strong people leader with effective interpersonal skills. Ability to explain difficult or sensitive information. Works to build consensus.
Knowledge of FDA, EU, Canada product registration regulations.
Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports.
Attention to detail and results-oriented.
High level of integrity
Travel: Travel expectations for this role are approximately -15%
To Apply: http://bit.ly/2Eqa2Fa
Leica Biosystems is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
Additional Salary Information: Bonus
Internal Number: R1103902
About Leica Biosystems
Leica Biosystems is a global leader in workflow solutions and automation designed to help pathology laboratories and researchers shorten the time between biopsy and diagnosis. You’ll contribute to our mission of advancing cancer diagnostics to improve patients’ lives.
We offer a comprehensive range of products for each step in the pathology process, and make significant investments in new product development to continually improve our offerings. Recent innovations have focused on digital pathology and the launch of next-generation scanners and histology equipment, and we have set our sights on making diagnosis within 24 hours of a biopsy possible.
Through Vision 24, our commitment to process improvement, efficiency and superior quality is helping to speed time to treatment. For anxious patients awaiting crucial information about their health, shortening wait time is a game changer. And, for pathologists, our integrated solutions provide a superior level of confidence around the chain of custody for their tissue samples.
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