Senior Regulatory Affairs Specialist in Vista, California at Leica Biosystems

Date Posted: 2/8/2018

Job Snapshot

Job Description

Job ID: PAT000446

About Us

Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps.  Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Visit LeicaBiosystems.com  for more information.


Description

Position Summary and Overview 

The primary role of the Senior Regulatory Affairs Specialist is participating on Leica Biosystems New Product Development Teams, the preparation and submissions of regulatory filings required to market new or modified in-vitro diagnostic devices in the US including all relevant maintenance activities and to support of regulatory submissions and registrations in applicable Global markets.

Major Responsibilities 
  • Acts as a core member on New Product Development teams providing regulatory and compliance guidance, and develop regulatory strategies and timelines.
  • Supports development and implementation of regulatory strategies for new and current products.
  • Prepares documents necessary for new product market clearances, approvals, and continuance during product life cycle management that includes (but is not limited to) 510(k)s, supplements, and technical files for CE marking.
  • Participates in the review and submission activities (annual reviews, change notifications, etc.) supporting the maintenance of Global regulatory and marketing approvals. 
  • Prepares and/or compiles information required by Global regulatory associates to support submission, registration or licensing products outside the U.S.
  • Acts as a company representative, developing, maintaining professional relationships with applicable regulatory bodies (e.g. FDA, CFDA, PMDA).
  • Interacts with the Research and Development Organization, and other cross-functional departments, ensuring proper coordination of information and data to support global regulatory filings (US and Global).
  • Reviews regulatory and compliance publications to disseminate relevant regulations, guidelines & policies to all functional departments.
  • Revises product/device labeling and advertising materials to ensure compliance with global regulations; analyzes and provides recommendations for appropriate changes. 
  • Supports & participates in inspections/audits by the notified body and/or other global regulatory agencies and internal audits.
  • Work closely with the Quality Organization to enact continuous process improvement and compliance with changing U.S. and Global regulatory requirements/standards. 



 



Job Requirements



Qualifications

Required Skills/Experience/Education 

  • Minimally a Bachelors degree in a scientific discipline (e.g. Biology, Biochemistry, Chemistry, Engineering) 
  • Minimum of 5+ years related regulatory affairs/compliance experience and/or training or equivalent combination of education and experience in diagnostics or medical device manufacturing. 
  • Knowledge and experience in U.S and Global Medical Device and IVD regulations and standards
  • Advanced technical writing skills (e.g. regulatory documentation, scientific presentations)
  • Current knowledge, experience and understanding of U.S. and Global Medical Device and IVD regulations and standards (e.g. FDA QSR 21 CFR 820, IVD Directive, ISO standards)


Desired Skills/Experience 

  • Effective presentation/communication skills. 
  • Project/resource management skills.
  • Ability to work independently and in a team environment.
  • Problem solving and root cause analysis skills
  • Capability to keep current on new and existing global regulatory standards and requirements


Language

  • Effective English communication skills


Travel

  • <10%



All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check. 



Leica Biosystems Imaging, Inc. 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.


To Apply:

Leica Biosystems is committed to attracting and retaining the most highly qualified candidates available. We firmly believe that our employees drive the success of the company.  As a Leica Biosystems employee you will be consistently challenged to deliver your best. 


For consideration, please complete the on-line application and submit your resume.


Leica Biosystems pays salaries commensurate with market value, and provides exceptional benefits.

Leica Biosystems is an Affirmative Action and Equal Opportunity Employer:  Race, Color, National Origin, Religion, Sex, Disability, Vet, Sexual Orientation, and Gender Identity.

Be sure to follow Leica Biosystems on LinkedIn!


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