- Review regulatory submissions for new products and product changes as required to ensure timely approval for clinical studies and product market release. Review significant regulatory strategies with leadership team, as necessary..
- Provide on-going support to core and project teams for regulatory issues and questions. Investigate, interpret and apply regulations and guidance appropriately for situations.
- Review business and product information to RA Leadership to enable development of strategies and requirements to communicate information to leadership team.
- Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling, promotional materials, changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.
- Work with RA Leadership and other members of the RA team to help support discussions with FDA or other regulatory agencies, as needed. All significant changes will be reviewed with the RA Leadership.
- Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
- Interact frequently with different members of the organization and outside customers.
- Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
- Review training, promotional and advertising pieces for assigned product lines.
- Provide training and support to other members of the organization.
- Support Quality Systems Projects as required.
- Adhere to all company policies, procedures, and business ethics codes.
- Duties may be modified or assigned at any time based on business need.
- Bachelors degree in science, engineering, or related discipline
- 2+ years of experience in regulatory affairs within the medical device space
- Demonstrated proficiency with global regulatory planning and strategy for submission preparation (including but not limited to 510(k), IDE, supplements, and amendments)
- Clinical, Quality or Regulatory compliance experience
- Experience with product lifecycle management, premarket and post-market product line support.
- Strong understanding and wide application of technical or regulatory principles, theories, and concepts; general knowledge of other related disciplines
- Level and compensation depends on location, experience, education and skills
- Ability to provide solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practical, and consistent with organizational objectives.
- Ability to analyze a wide range of information, including conflicting and ambiguous inputs and propose solutions.
- Strong organizational, time management and project management skills
- Strong knowledge of Microsoft Office
- Effective presentation and interpersonal skills
- Self-motivation
- Excellent verbal/written communication skills
- Strong attention to detail and accuracy
- Ability to communicate persuasively in a manner that supports approvals and other key company goals/objectives.
- Must be able to communicate verbally and in writing, and to receive and understand verbal and written instructions in English
- Able to work effectively both independently and in a collaborative team environment.
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Regulatory Affairs Specialist - Irvine, United States - Nihon Kohden
Description
The Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for the organizations products. Work with RA Leadership and other members of the RA team to set strategy for regulatory approval to introduce new products to market, provide advice on regulatory requirements and prepare regulatory submissions.
Essential Functions and Main Duties
Qualifications
Education / Certification / Experience Required
Competencies Required
Compensation
The anticipated range for this position is $34.00 to $47.00. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.
Perks & Benefits
Visit our Career page to learn more about Perks & Benefits and working at Nihon Kohden America
Working Conditions
Schedule: The regular hours for this temporary position are 8:00 a.m. to 5:00 p.m., MondayFriday, unless otherwise stated by the department manager. Holiday, weekend, and evening work hours may be required. Regular hours may vary due to the needs of the organization or department and are subject to change at any time at the Companys discretion.
Physical: Generally, may require some reaching, bending, stooping, squatting, crawling, kneeling, pushing, pulling, lifting, carrying up to 20 pounds, finger dexterity, repetitive motions, standing, walking, sitting, hearing, visual acuity, color vision, and 2-way written/verbal communication in English. More specific details may be provided as needed or requested.
Travel: Not Required
Access to Customer Sites: Not Required
Nihon Kohden Americas official EEO policy statement follows. In keeping with this policy, Nihon Kohden America will continue to recruit, hire, train, and promote into all job levels the most qualified persons without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability, or because he or she is a protected veteran. Similarly, Nihon Kohden America will continue to administer all other personnel matters (such as compensation, benefits, transfers, layoffs, company-sponsored training, education, tuition assistance, and social and recreational programs) in accordance with Company policy. Nihon Kohden America bases employment decisions on objective standards as much as possible in the furtherance of equal employment opportunity.
If you have a disability under the Americans with Disabilities Act or similar law, or you require a religious accommodation, and you wish to discuss potential accommodations related to applying for employment at Nihon Kohden, please contact Human Resources.
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