Superior Jobs


Regulatory Affairs Professional 3

  • ID: 491954
  • Posted: 9/13/2021
  • Location: Mountain View, CA
  • Category: Pro - Professional
  • Job Type: Temporary
  • Duration: 9 - 12 Months


Acara Solutions is looking for an Regulatory Affairs Professional for our Client located Mountain View, CA.
  • The Regulatory Clinical Affairs Specialist, EU MDR is a member of the Clinical Affairs team and he/she shall plan, coordinate and implement Standard Operating Procedure (SOPs)/Work Instructions (WIs), templates and trainings for various stakeholders related to Clinical Lifecycle Management for Client Ultrasound systems and intracardiac echocardiography (ICE) catheters.
  • This position is responsible for supporting implementation of European Medical Device Regulations (EU MDR) within the Quality Management System.
  • Participate in communications regarding overall direction and guidance to the cross-functional project team on clinical evaluation, PMCF and clinical development activities.
  • Plan, execute, and finalize all QMS deliverables for clinical workstream for CE marking products per MDR including but not limited to clinical evaluation plan (CEP), CER, PMCF plan, PMCF Report, Summary of safety and clinical performance etc.
  • Coordinate efforts of project teams with third party/outsourcing vendors to achieve clinical deliverables.
  • Identify, effectively communicate and resolve EU MDR project issues, risks and develop mitigation plans.
  • Effectively communicate project status to project stakeholders and EU MDR core team.
  • Develop training materials and support overall training strategy for all stakeholders including but not limited to Foster Product Managers, Risk managers and Post-market managers into the CE marking deliverables for each project.
  • Provide support as need during internal as well as external Audits by TUV and FDA
  • Prioritize robust SOPs/WIs and templates at all times and identify continuous areas of improvement.
  • Proactively work to improve systems and procedures and act as a cross-functional liaison with legal, quality, product management and clinical teams.
  • Develop/maintain SOPs, processes, and templates to strategically standardize clinical tasks and improve efficiency.
  • Perform periodic reviews of risk management files, usability engineering files, product labeling, and marketing claims as part of the clinical evaluation process.
Pay and Benefits:
  • The Salary for this position is $ 48.00 per hour (Max Pay rate).
Job Requirements

Required Skills / Qualifications:
  • Bachelor"s degree 
  • Minimum of 7 years" experience in clinical and regulatory affairs
  • Minimum of 5 years" experience in research methodology (clinical investigation design, biostatistics), scientific literature review (PUBMED, EMBASE, MEDLINE etc.) and medical writing.
  • Minimum of 5 years" experience in FDA (21 CFR 212, 21 CFR 820 etc.) , EU (MDR, MDD, MEDDEV 2.7/1), ISO 14155/GCP and other regulatory standards.

Preferred Skills / Qualifications:
  • Master"s Degree in clinical and regulatory affairs
  • Experience in claims management and mapping clinical evidence to clinical claims.
  • Experience In EU clinical trials and experience with Institutional Review Boards (IRB) and Ethics Committee (EC).
  • Experience with regulatory submissions for EU Class III devices .
  • Demonstrated project management and planning experience.
  • Demonstrated problem solving capability and results orientation.
  • Strong critical/analytical thinking and problem solving skills.
  • Strategic planner, self-starter, collaborative team player and clear thinker.
  • Excellent interpersonal, written / verbal communication and presentation skills.
  • Ultrasound and imaging catheter experience preferred.
  • Advanced degree (MD, PharmD, PhD etc.) and experience in radiology, cardiology and medical imaging.
  • In-depth understanding of EU MDR and Risk Managemen.
  • Regulatory Affairs experience for EU CE Marking and supporting technical documentation.
  • Key Working Relationships
  • Works with a cross functional team.
Additional Information:
  • Upon offer of employment, the individual will be subject to a background check and a drug screen.

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.

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