Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
eTeam was formed in 1999 with the goal of becoming the supplier of choice for clients, employees and contingent workers. Today, we’re one of the fastest-growing companies in New Jersey and ranked as one of the best companies to work for by Staffing Industry Analysts and New Jersey Business. We’re also an honored member of Deloitte’s Technology Fast 50
Regulatory Affairs Specialist position: • Exhibit a competence in US & foreign government regulations regarding the manufacture & distribution of medical devices • Assist with activities necessary for the timely preparation, writing & submitting of international registrations (technical files), & all related amendments & supplements. EU experience with Dossiers and technical files a plus • Exhibit competence in preparing, writing & filing regulatory documentation • Manage a significant amount of proprietary information in an extremely confidential manner • Possess strong project management skills • Possess good oral communication skills -presentation & meeting interactions • Work as a self-starter - work effectively with some supervision • Possess strong problem-solving & priority setting • Exhibit strong decision making - numerous independent decisions every day & must therefore have the ability & confidence to effect informed decisions based upon regulatory expertise, government constraints, & a thorough understanding of business needs
Education requirements: 1. Bachelor degree from accredited college or university in science, biomedical engineering, medical / scientific writing, public health administration 2. Advanced degree is desirable 3. RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, desirable 4. Evidence of foreign regulatory approval / clearance of new or modified medical devices; experience with higher risk device desirable 4-6 years of successful experience conducting regulatory activities that achieved domestic & foreign regulatory
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Neha Sharma
Lead Recruiter
eTeam Inc – “ACCELERATED HIRES”
Efficiency, Synergy, Expertise
T-732-248-1900 .Ext 120
Awards
#1 Best Places to work in New Jersey-2009,2008,2007,2006
Top Small Diversity Business, 2006 by DiversityBusiness.com
Deloitte Technology Fast 500-2007,2006
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