Quality Assurance and Regulatory Affairs Analyst

Responsibilities:
  
Auditing
Conducting internal audits, supplier audits, and coordinating external audits.
Recording and rating audit findings to clearly identify nonconformities and the level of regulatory risk posed
Representing the company on medical device quality and regulatory matters during external audits and inspections.
Regulatory Artifacts
Developing artifacts required for new and renewed registrations and licenses (for products and establishments), as required.
Obtaining new and renewed registrations and licenses (for products and establishments) from the appropriate medical device regulatory authorities
Reviewing product-related records that require regulatory affairs oversight.
Regulatory Research
Regularly researching the medical device regulatory requirements in the jurisdictions in which IWCS markets and plans to market its products.
Producing summaries of the updated regulatory/standards requirements landscape and providing access to associated current regulations and standards.
 
Regulatory Interpretations
Providing subject matter expertise on the many regulations and standards that govern IWCS’s operations.
Regulatory Reporting
Conducting the regulatory response to customer complaints involving patient safety issues, including reporting to regulatory agencies of incidents/near-incidents and recalls involving IWCS medical devices, as required.
 
Training
§ Providing training on the governing standards and regulations relevant to IWCS’s quality system.
Continuous Improvement
Completing corrective actions to address audit findings relevant to QARA processes and procedures in a timely manner;
Proactively improving QARA processes and procedures.
Performing trend analysis and quality metrics.
 
Job Challenges:
Needs to be able to influence peers and management staff.
Meeting deadlines in a fast-paced environment.
Needs to be able to work remotely with international locations in other time-zones.
Requires in-depth knowledge of applicable regulatory requirements.
May involve periods of personal stress.  
Occasional international travel required.
  
Qualifications Required:
     a) Education:  Bachelor
face=”Times New Roman (כותרת עליונה)” size=3>’s degree in related discipline
     b) Experience:  
Minimum 4 years in a medical device, life sciences or similar industry.
Experience in a software development industry preferable.
Experience in performing internal/external/supplier audits preferable.
    c) Background:  Working knowledge of medical device regulations and standards applicable to IWCS products, including:
ISO 13485 Medical Device Quality System Requirements,
ISO 14971 Medical Device Risk Management
FDA Quality System Regulation (21 CFR 820)
Canadian Medical Devices Regulations (SOR/98-282)
European Medical Device Directive EU MDD 93/42/EEC
   
Critical Skills:  
Fluency in English – verbal, written and presentation skills.
Proficiency with all Microsoft Office applications, project management tools, and electronic document control tools.
Strong technical, organizational, and interpersonal skills.
Ability to prioritize, multi-task and perform in a deadline-oriented environment.
Excellent problem solving/decision making skills.
Strong project management and time management skills.
Ability to work closely with multiple internal, external and cross functional teams.
Ability to work in a fast-paced environment and have a strong sense of ownership.
Proactive, collaborative, self-motivated, team player.