Regulatory Affairs Specialist in Tewksbury, Massachusetts at AccruePartners

Date Posted: 9/24/2020

Job Snapshot

Job Description

AccruePartners values our contract and consulting employees. We offer a competitive benefits package to meet the diverse needs of all of our contractor and consulting employees and their family members. Here is a listing of what our company offers: 401(k) Medical, Dental, Vision, Life Insurance, Employee Assistance Program, Medical and Prescription Drug, Short and Long-Term Disability Insurance. 

THE TEAM YOU WILL BE JOINING:

  • Fortune 500 manufacturing and technology organization with significant investment in R&D and Innovation
  • Rich history with over 150 years of significant growth and innovation
  • Expanding global footprint in North America, South America, Europe and Asia
  • Industry leader within all 8 divisions and leader in each
  • Known for growing talent internally and promoting internally

WHAT THEY OFFER YOU:

  • Culture: Highly collaborative, teamwork-oriented environment
  • Growth: Make an immediate impact in this high visibility role
  • Opportunity: Ability to drive change within organization with a focus on process improvement
  • Stability: Strong executive leadership team investing in its talent and elevating the global footprint

WHERE THIS POSITION IS LOCATED:

  • Tewksbury, MA

WHY THIS ROLE IS IMPORTANT:

  •  Coordinate, prepare or maintain regulatory filings or submissions to obtain and sustain product approval.
  • Support regulatory plans for assigned products.
  • Document and maintain regulatory procedures, work instructions, or policies.
  • Review promotional materials, labeling, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Support regulatory related projects (UDI, EU MDR/IVDR, LVD, EMC).
  • Conduct New Product Review using SharePoint based system.
  • Participate on new product project teams and provide inputs for premarket regulatory requirements, labeling requirements, or clinical study.
  • Review proposed product, label or manufacturing changes for regulatory impacts.
  • Stay updated on existing and changing regulations, standards, or guidance documents.
  • Support internal and external audits.
  •  Research and interpret regulations to apply to appropriate product lines.
  •  Prepare and support responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Support post-market surveillance, vigilance and field action activities.
  •  Compile and maintain regulatory documentation databases or systems

BACKGROUND THAT FITS:

  • Bachelor’s Degree in technical specialty required (engineering, chemistry, or biology)
  • 2 years of regulatory affairs or quality experience in life sciences, medical device, in vitro diagnostics or regulated industry
  • Strong technical writing skills and attention to detail
  •  Proficient in information technology tools including electronic document management systems and Microsoft Office Applications: MS Word, Excel, PowerPoint
  •  Effective written and verbal communication skills across all levels of the organization
  •  Must be an effective communicator, and able to deliver messages through presentations, written and verbal communication
  •  Utilizes sound and rational problem solving and decision-making processes
  •  Ability to handle multiple tasks concurrently and in a timely fashion
  • Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals
  • Must display eagerness to learn and continuously improve
  •  Positive work attitude that supports teamwork and continuous improvement
  •  Experience with regulations related to medical device, IVD, or biopharma products
  •  Experience with FDA 21 CFR 820, ISO 13485, ISO 9001, or similar
  • Previous regulatory submission experiences (FDA 510k, CE Mark, eCTD, etc)
  • Familiar with UDI, EU MDR/IVDR, LVD, EMC regulations.