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 client's products.Essential Duties and ResponsibilitiesSupports regulatory project plan executionMaintain awareness of regulatory requirements and ensure continued learningMaintain regulatory files in a format consistent with requirementsParticipate as an active team member of project teams as requiredCompile and prepare responses to questions from regulatory authorities according to planEdit and proofread regulatory documentationAssist in preparation and review of labeling, SOP’s, and other departmental documentsCompile under supervision regulatory documents for submissionTrack status and progress of regulatory documentationUnderstand Regulatory Affairs' position in small project teamsQualificationsKnowledge of regulationsScientific knowledgeAdministrative and project management skillsAbility to contribute to multiple projects from a regulatory affairs perspectiveAbility to multitask and prioritizeInterpersonal and communication skillsTechnical system skills (e.g. word processing, spreadsheets, databases, online research)Proofreading and editing skillsEducation and/or ExperienceBachelor’s degree or country equivalent in a relevant scientific disciplineSuitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualificationRegulatory experience (not mandatory) preferably within a healthcare environmentTop 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 devicesNotes:Remote positionSchedule (flexible)
At VIVA, employee well-being is paramount. Our comprehensive benefits package ensures your health, financial security, and quality of life are always prioritized.
VIVA provides employees access to a comprehensive group health insurance plan (Medical, Dental, Vision, Basic Life, Term Life, and Accidental Death) through our flexible PPO plan-allowing you the freedom to choose healthcare providers.
Plan securely for your future with automatic payroll deductions into a tax-advantaged 401(k) retirement plan, including employer-matching contributions for eligible employees.
Earn performance-based bonuses and generous referral incentives of up to $500 when recommending talented candidates who become part of the VIVA family.
Enjoy timely and convenient payroll with biweekly direct deposit to your chosen financial institution. Biweekly Direct Deposit
Access exclusive employee discounts and savings on electronics, travel, groceries, apparel, and more through our dedicated VIVA Perks Program.