Software Regulatory Affairs Specialist

The Software Regulatory Affairs Specialist is responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for the organization's products. Working closely with all departments to develop and execute regulatory strategies. Set strategy for US FDA and MDR and other regions around the world clearance/approval to introduce new products to market, provides advice on regulatory requirements and prepares submissions.

Essential Functions and Main Duties

• Responsible for regulatory compliance, per Article 15 of the EU MDR
• Prepare submissions for new products and product changes as required to ensure timely approval for market release. Review significant regulatory strategies with leadership team, as necessary, and negotiate submission steps with regulatory bodies.
• Prepare regulatory strategies/plans and requirements list. Provide on-going support to core and project teams for regulatory issues and questions. Find, interpret, and apply regulations and guidance appropriately for situations.
• Provide business and product information to Director of Software Quality to enable development or strategies and requirements and communicate information to leadership team.
• Provide regulatory support for currently marketed products, as necessary. This includes reviewing and approving labeling, promotional materials, changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.
• Negotiate directly with the FDA or other international agencies, as needed. All significant changes will be reviewed with the Director of Software Quality.
• Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
• Facilitate FDA pre submission meetings,
• Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures.
• 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 department.
• Manage FDA and California Establishment Registrations and Listings.
• 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 biology, Engineering or related science required Regulatory Affairs Certification, preferred.
• 2+ years of experience in/ Regulatory Affairs experience or capacity
• Preferred experience in software as a medical device and software industry
• Complete understanding and wide application of technical or regulatory principles, theories and concepts; general knowledge of other related disciplines
• Level and compensation depends on 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.
• Strong problem-solving skills. Ability to analyze a wide range of information, including conflicting and ambiguous inputs and propose solutions.
• Strong organizational, time management and project management skills
• Demonstrated ability to independently assess risk and develop solutions to critical and difficult problems that are consistent with organizational 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 $120,000. 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

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, color vision, and 2-way written/verbal communication in English. More specific details may be provided as needed or requested.

Travel: Minimal

Access to Customer Sites: Not Required

Nihon Kohden America's 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.