Regulatory Affairs Specialist- $50+/hr

Regulatory Affairs Specialist- $50+/hrResponsibilities Lead preparation and submission for regulatory approvals and acts independently to identify and resolve problems Provide regulatory guidance to cross-functional partners and demonstrate strategic thinking and creativity in support of programs Prepare robust regulatory applications to achieve departmental and organizational objectives File necessary applications and handle all government interactions pertaining to the regulation process for products requiring governmental approval Author and submit PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports) Review/approve engineering study protocols/reports and validation study protocols/reports Review and approve manufacturing changes for Class III implantable medical devices Create, review and approve engineering change orders Act as regulatory representative on core product development teams Communicate regulatory requirements and impact of regulations to the development team Act as liaison between Company and various appropriate regulatory agencies Maintain ongoing surveillance and analysis of all pertinent domestic and international medical device regulations Ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission database Ensure information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate Review device labeling and marketing materials for compliance with FDA submissions and applicable regulations Interface directly with FDA and other regulatory agencies Support product release process by creating GTS licenses or reviewing and approving requests for product release Conduct reviews of product and manufacturing changes for compliance with applicable regulations Review protocols and report to support regulatory submissions Comply with (FDA) and international regulations, requirements, policies, operating procedures, and processes Maintain communications and collaboration with all levels of employees, customers, contractors, and vendorsQualifications BA/BS degree 4+ years of regulatory experience in a medical device industry Experience with Class III implantable medical devices Knowledge of FDA PMA guidance documents and CFR regulations Experience with 510(k) applications, PMA supplements and US/ international medical device regulations Strong communications with ability to effectively communicate at multiple levels in the organization Strong organizational and follow-up skills, as well as attention to detailOur client is a worldwide industry leading healthcare company that's been in business for over 100 years with an annual revenue of $27 billion.Collaborative Staffing prides itself on being a company that maintains a strong commitment to pairing prospective job seekers with desirable positions among top companies throughout the nation.