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Regulatory Affairs Subject Matter Expert II

Your Role:

The Regulatory Affairs Subject Matter Expert will ensure that departmental objectives are implemented in line with the overall site, department, and corporate goals and objectives.  You will be dedicated to ensuring continual compliance to all applicable regulations. Manage assigned regulatory tasks related to health authority notifications / submissions / registrations regarding new products, changes to products or sale of products in new territories. Ensure site regulatory strategy aligns with overall corporate regulatory strategy, goals and objectives. Carry out regulatory review of documents and changes. Carry out impact assessments where required.  Review customer complaints for incidents requiring vigilance reporting or regulatory involvement. as assigned through the Quality System as appropriate. 

In this role you will also assemble and maintain technical files, device master records and other regulatory documentation to ensure current, and changes recorded.  Maintain library/database of standards and regulation. Review of updated standards and regulations, carry out documented review, ensuring any necessary updates are made and disseminating information throughout the site.  Manage regulatory review for new product introductions, CAPA investigations, printed materials, validations and general projects.  Support preparation of and participate in any customer audits which require regulatory input.  Support preparation for and participate in audits by regulatory bodies.  Carry out regulatory gap analysis and audits related to changing or new regulations.  Respond to customer (internal & external) regulatory requests or enquiries.  Support any recall or notification actions & carry out regulatory vigilance reporting as required.  Act as liaison between site and notified body or other regulatory authorities.

 

Who you are: 

 

Minimum Qualifications:  

  • Bachelors’ Degree in biology, biochemistry, or similar life science discipline
  • 3+ years of work experience in a Regulatory Affairs environment
  • 3+ years of experience working with FDA medical device regulations, particularly for Class I medical devices/IVDs; Research Use Only (RUO), Analyte Specific Reagents (ASRs), and labeling requirements for these product types
  • 3+years of experience working with IVDD, transitioning to IVDR to be able to provide regulatory guidance
  • 3+ years of experience working with EU medical device regulations
  • 3+ years of experience working with technical files
  • 3+ years of experience working with requirements in U.S., E.U.
     

Preferred Qualifications:

  • Familiarity with global regulations, Asia, Latin America, Eastern Europe, Africa, Middle East,
  • Familiarity with global requirements for IVD product registrations
  • Experience managing regulatory mitigation projects
  • Experience writing regulatory assessments and risk assessments related to regulatory guidance and advice to the site
  • Highly cooperative and collaborative
     

 RSREMD

 

Job Requisition ID:  197052
Location:  Rocklin
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Biochemistry, Medical, CAPA, Medical Device, Science, Healthcare, Management, Customer Service

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