Associate Regulatory Affairs Specialist

US, US, CA - Aliso Viejo

Minimum Level of Education Required: Bachelors Degree

Percentage of Travel: Up to 10%

Location: CA - Aliso Viejo

Ref#: 17406

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Job Description

This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry and maintenance.

Job Description

·        Prepares robust regulatory applications to achieve departmental and organization objectives

    • 510k (Special, Traditional)
    • Global Registrations / Submissions
    • Audit Support – FDA and Notified Body
    • UDI management
    • MDR management

·        Creates, reviews and approves change orders as required

·        Act as a core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed

·        Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA and other worldwide regulatory agencies to various international affiliates

·        Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission database and file systems

·        Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel

·        Support interactions with FDA and other regulatory agencies

·        Supports the product release process by creating or reviewing and approving requests for product release

·        Reviews protocols and reports to support regulatory submissions

·        Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments

·        Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

·        Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements

Basic Qualifications

·        BA or BS degree, technical discipline preferred

·        Experience in the Medical Device Industry

·        Minimum 3 years of experience, including a minimum of two years regulatory experience

·        Experience with either 510(k) submissions and US device regulations;

·        Experience with EU and other international medical device regulations and submissions

·        Ability to work in a fast paced startup business environment

·        Ability to work within a team and as an individual contributor in a fast-paced, changing environment

·        Ability to leverage and/or engage others to accomplish projects

·        Strong verbal and written communications with ability to effectively communicate at multiple level in the organization

·        Multitasks, prioritizes and meets deadlines in a timely manner

·        Strong organizational and follow-up skills, as well as attention to detail

·        Experience working in a broader enterprise/cross-division business unit model

Preferred Qualifications

ISO13485:2016 and MDSAP implementation experience

Clinical experience a plus

NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes.The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.
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