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Job Field: Legal Jobs
Location: San Diego, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>1. Responsible for management of preparation and maintenance of both U.S. regulatory submissions and other premarket filings and registrations to acquire appropriate commercial distribution clearances in an expeditious manner.
2. Determine/document appropriate regulatory strategy for proposed new products and initiate necessary activities by working with Regulatory management as needed.
3. Support ensuring that quality system activities are in place and are conducted in accordance with applicable regulations and standards including, but not limited to, U.S. FDA Quality System Regulations, ISO International Organization for Standardization Standards, and the European MDD Medical Device Directive.
4. Control and maintain regulatory records.
5. Represent Regulatory Affairs on various design and development teams by attending team meetings and providing the required plans, procedures and regulatory decisions. Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
Bachelors degree from four-year college or university in addition to two 2 to five 5 years related experience Up-to-date knowledge of U.S. regulatory and quality, standards, and foreign directives and regulations applicable to NuVasive operations and business objectives.
Computer Skills
Proficient and accurate with word processing Word, spreadsheets Excel, presentation programs Power Point, charting, flow charting, and graphs. Competency in navigating the Internet.
Language Skills
Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents. Ability to respond to inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.
Mathematical Skills
Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Other Qualifications
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- Strong knowledge of US FDA Quality System Requirements QSR, and ISO 13485, various international regulations.
- Experience with orthopedic implant product design and project development
- Experience in medical device or pharmaceutical industry
- Must be detail oriented  highly organized
- Ability to work independently and exercise judgment with limited supervision
- Must possess strong interpersonal communication skills.
- Ability to prioritize workload with limited supervision
- Must demonstrate teamwork building skills in  outside department.
- Ability to exercise judgment
- Ability to prioritize workload with limited direction
Experience Required
Bachelors degree from four-year college or university life science background or engineering preferred
Requires 2-5 years experience in Regulatory Affairs with US pre-market submissions experience
NuVasive is an Equal Opportunity Employer

KEY REQUIREMENTS:

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2 years Bachelors degree