The Regulatory Affairs Specialist is responsible for investigating and supporting regulatory policy necessary to obtain regulatory approval for the organization's products. Work with RA Leadership and other members of the RA team to set strategy for regulatory approval to introduce new products to market, evaluate regulatory requirements and prepare regulatory submissions.

Essential Functions and Main Duties

• Prepare 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, and negotiate submission steps with regulatory bodies.
• Provide on-going support to core and project teams for regulatory issues and questions. Investigate, interpret and apply regulations and guidance appropriately for situations.
• Provide 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.
• Participate in the development of general strategies, including how to interact more effectively with regulatory agencies and agency personnel.
• Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
• 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.
• Support maintenance of facility licenses such as FDA Establishment Registrations, California FDB Licensing, Health Canada etc.
• 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.

Qualifications

Education / Certification / Experience Required:

• Bachelor's degree in science, engineering, or related discipline.
• 2+ years of experience in regulatory affairs
• 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 depend on location, experience, education and skills

Competencies Required:

• 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

Compensation

The anticipated range for this position is $80,000 to $100,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.

Perks and 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 full-time position are 8:00 a.m. to 5:00 p.m., Monday-Friday, 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 Company's 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, and color vision. More specific details may be provided as needed or requested.

Travel: Approximately 10%

Access to Customer Sites: Not Required