Job title: Sr. Regulatory Affairs Contractor Duration: 2 years, 7 months REMOTE role
Need someone who is bilingual in French.
Summary Description:
Independently provide EU regulatory requirements and guidance to EU MDR project teams.
Lead the preparation of the EU MDR technical documentation for Class III, IIa, IIb, or Class I sterile or reusable medical devices to support timelines for CE marking and EU commercial release.
Lead the submittal of the EU MDR technical documentation for Class III, IIa, or IIb medical devices and collaborate with the cross-functional team and Notified Body to respond to any questions during the review.
SUPERVISION RECEIVED: Under minimal supervision of Sr. Manager or Director of Regulatory Affairs SUPERVISION EXERCISED: None
ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Primary responsibilities are to:
Serves as the Regulatory Affairs lead on cross-functional MDR project teams
Ensures compliance with EU Medical Device Regulations (MDR) and EU guidance throughout the project.
Actively participates in EU MDR project teams by attending meetings, collaborating with the project manager and cross-functional team members, and communicating regulatory requirements and guidance for the technical documentation.
Review change orders associated with the MDR project deliverables.
Writes and assembles information necessary for the technical documentation and works with the publishing department to finalize submission.
Leads the prepation of the General Safety and Performance Requirements (GSPR) with the crossfunctional team.
Prepares and submits EU MDR technical documentation submission for applicable device per project schedule.
Collaborates with the cross-functional team to respond to requests from EU Notified Body during the MDR technical documentation review.
Prepares regulatory strategy to globally communicate and assess changes in scope of MDR project
Helps provide solutions to problems of moderate scope and complexity
DESIRED MINIMUM QUALIFICATIONS
Bachelor’s degree in Science, Engineering, Regulatory Affairs, or other technically related field.
Minimum of 3-5 years regulatory experience in a regulated industry such as Medical Devices, Biotech or Pharma
xcellent written and verbal communication skills.
Experience in the preparation and submission of EU MDR technical documentation submissions, including EU Class II and III devices.
Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to MDR project teams.
TOOLS AND EQUIPMENT USED Normal office environment: must be computer literate and familiar with Microsoft Suite of Products including Word, Excel, Outlook or similar.
Note: The Company is committed to complying with the California Consumer Privacy Act (“CCPA”) effective January 1, 2020; and all data privacy and laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $54.00/hr.
