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Regulatory Affairs Professional 2

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  • ID: 492084
  • Posted: 9/15/2021
  • Location: Waltham, MA
  • Category: Pro - Professional
  • Job Type: Temporary
  • Duration: 6 - 9 Months

Description

Acara Solutions is looking for a Regulatory Affairs Professional 2 for our Client located in Waltham, MA.
  • This position is responsible for the creation, preparation and coordination of regulatory submissions and approvals in the domestic and international markets. 
  • As part of a multi-disciplinary group, this position contributes to the design, development and product launch of Corindus’ innovative robotic systems that bring improved care to patients and physicians.
  • Work with the Manager of Regulatory Affairs to determine effective regulatory pathways for a variety of projects and issues
  • Prepare document packages for regulatory submissions including 510(k)s, Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions, and Pre-market Approval Applications
  • Track and coordinate regulatory submission activities to ensure timeliness and commitments are met
  • Coordinate responses to regulatory agencies and notified bodies as part of the submission and approval process
  • Review and approve Engineering Change Orders in accordance with regulatory requirements
  • Participate in new product development teams and communicate regulatory requirements for product development; facilitate internal compliance with those requirements
  • Review and approve test protocols to support regulatory submissions
  • Review device labeling and advertising material for compliance with submissions
  • Assist in regulatory compliance activities, including but not limited to Notified Body Audits, FDA Inspections, and other regulatory agency inspections and audits
  • Maintain regulatory files
  • Perform internal audits of the Quality System
  • Analyze product complaints and make recommendations regarding their reportability
  • Other duties as assigned
 
Pay and Benefits:
 The salary for this position is $35.00 per hour (Max Pay rate).
 
Job Requirements

 
Required Skills / Qualifications:
  • Bachelor’s in Engineering or Science. 
  • Minimum 2 years’ experience in a medical device or biotech or pharmaceutical environment.
  • Minimum 2 years of Regulatory submission experience in US and EU. 
Preferred Skills / Qualifications:
  • Regulatory compliance experience in the medical device area.
  • Knowledge of applicable US and EU medical device regulations. 
  • Knowledge of other markets
  • Working knowledge of GMPs and GCPs 
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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