Regulatory Affairs Specialist

  Responsibilities:
• Conducts 510(k) and CE Mark impact assessments
for product changes.  
• Co-authors 510(k) submissions and significant
change notifications for product changes with moderate business impact.  
• Maintains letter-to-file history and updates
technical documentation as needed in support of product changes/life cycle
management and post-market data.  
• Monitors and coordinates maintenance of global
product registrations, product regulatory certificates, business licenses (e.g.
CDPH), and establishment registrations.  
• Maintains regulatory databases such as FURLS,
GUDID and EUDAMED to ensure data accuracy. • Ensures service continuity with
key 3rd party regulatory services (e.g. contract regulatory representatives,
standards maintenance service, etc.)  
• Monitors product shipment eligibility based on
market clearance/approvals as communicated by senior RA personnel.  
• Coordinates notaries, legalizations, and
apostilles in support of product registrations as needed. • Serves as the
department archivist following document retention guidelines for key RA
documentation. • Helps identify opportunities and implement process
efficiencies.  
• Supports interdepartmental information requests.
 
• Performs other regulatory-related duties as
assigned.   
 Qualifications:  
• BA or BS degree required; science, technology,
engineering and technology background highly preferred.  
• Minimum 2 years of previous experience working
in a regulated industry required; experience in the medical device field highly
preferred.  
• Minimum 2 year of regulatory affairs or
regulatory compliance experience required.  
• Familiarity with medical device regulations and
standards (e.g. 21 CFR 820.30, ISO 13485, IEC 62304, ISO 14971, ISO 10993,
etc.) preferred.  
• Strong attention to detail, interpersonal
skills, reading comprehension, organizational skills, multi-tasking, and
critical thinking/problem-solving skills required.  
• Experience with MS Word, MS Excel, and Adobe PDF
to compile and publish documents required.  
• Strong written and oral communication skills. 
Compile and
maintain regulatory documentation databases or systems.
Coordinate efforts associated with the preparation of regulatory documents or
submissions. 
Analyze
product complaints and make recommendations regarding their reportabsility.
Develop or conduct employee regulatory training.
Communicate with regulatory agencies regarding pre-submission strategies,
potential regulatory pathways, compliance test requirements, or clarification
and follow-up of submissions under review. 
Escort
government inspectors during inspections and provide post-inspection follow-up
information as requested.
 
Coordinate,
prepare, or review regulatory submissions for domestic or international
projects.
Interpret regulatory rules or rule changes and ensure that they are
communicated through corporate policies and procedures. 
Provide
technical review of data or reports that will be incorporated into regulatory
submissions to assure scientific rigor, accuracy, and clarity of presentation.
Review product promotional materials, labeling, batch records, specification
sheets, or test methods for compliance with applicable regulations and
policies.
Advise project teams on subjects such as premarket regulatory requirements,
export and labeling requirements, or clinical study compliance issues.  
Determine
the types of regulatory submissions or internal documentation that are required
in situations such as proposed device changes or labeling changes.
Identify relevant guidance documents, international standards, or consensus
standards and provide interpretive assistance.
Maintain current knowledge base of existing and emerging regulations,
standards, or guidance documents.