Randstad Regulatory Affairs Specialist in Andover, Massachusetts
Regulatory Affairs Specialist
salary:$55 - $60 per hour
date posted:Monday, January 7, 2019
industry:Professional, Scientific, and Technical Services
Regulatory Affairs Specialist
Randstad is looking for a Regulatory Affairs Specialist in Andover, MA
Medical Consumables and Sensors is a dynamic business that provides our client's Healthcare customers with over 1000+ quality medical consumable and sensor products spanning many clinical measurements and technologies including gas monitoring, fetal monitoring, invasive and non-invasive pressure, cardiac output, electrodes and lead wires for cardiac care, jaundice care, MR patient monitoring and others. The majority of products are procured from OEM suppliers/development partners. The position will be part of the MCS Quality and Regulatory organization located in Andover, MA. This role will have specific focus on the integration of additional SpO2 technology into our current SpO2 line.
location: Andover, Massachusetts
job type: Contract
salary: $55 - 60 per hour
work hours: 8am to 5pm
As a core member of multiple new product development teams, the Regulatory Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks:
Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.
Review and approve advertising, promotional items and labeling for regulatory compliance.
Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
Additionally, the Regulatory Specialist will:
Communicate application progress to internal stakeholders
Collaborate with worldwide colleagues regarding license renewals and updates
Maintain regulatory files and tracking databases as required
Communicate with regulatory agencies as needed
Mentor other regulatory affairs personnel within MCS
Bachelor's degree or equivalent internationally-acquired qualifications preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry
Minimum 3 years of regulatory approvals and submittal experience (EU MDD, Health Canada, USA, etc.)
skills: - Must be able to manage multiple tasks and perform with accuracy and a high attention to detail
Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
Proficient knowledge of domestic and international standards
Experience with FDA 510(k) submissions
RAPs RAC strongly preferred
Understand LEAN concepts, methodologies and deployment
Proficient computer skills in Microsoft Office
May require 5% travel annually with possibly some international
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.