Duties: Responsible for the global coordination and the preparation of documents/packages for regulatory submissions. In this position, you will also review and evaluate technical and scientific data and reports required for submission in support of global products.
Essential Duties and Responsibilities • Supports regulatory project plan execution • Maintain awareness of regulatory requirements and ensure continued learning • Maintain regulatory files in a format consistent with requirements • Participate as an active team member of project teams as required • Compile and prepare responses to questions from regulatory authorities according to plan • Edit and proofread regulatory documentation • Assist in preparation and review of labeling, SOP’s, and other departmental documents • Compile under supervision regulatory documents for submission • Track status and progress of regulatory documentation • Understand Regulatory Affairs' position in small project teams Qualifications • Knowledge of regulations • Scientific knowledge • Administrative and project management skills • Ability to contribute to multiple projects from a regulatory affairs perspective • Ability to multitask and prioritize • Interpersonal and communication skills • Technical system skills (e.g. word processing, spreadsheets, databases, online research) • Proofreading and editing skills Education and/or Experience • Bachelor’s degree or country equivalent in a relevant scientific discipline • Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification • Regulatory experience (not mandatory) preferably within a healthcare environment
What are your top three to five technical skill requirements? Familiar with USA and OUS device regulations (specifically EU device regulations) Experience with RA strategy development Experience with working with Cross functional team members Experience with interaction with external Regulators (FDA, TUV) Experience with working with medical devices
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: $37.50/hr.
