Senior Regulatory Affairs Specialist

Danvers, MA, United States

WHO WE ARE:

NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy, and accurate diagnostic solutions to healthcare providers. NeuroLogica is the global corporate headquarters and manufacturer of mobile computed tomography, and is also the US headquarters for sales, marketing, service and distribution of all Samsung digital radiography and ultrasound systems. Our advanced medical technologies are used worldwide in leading healthcare institutions, helping providers enhance patient care, improve patient satisfaction, and increase workflow efficiency. Samsung is committed to being a leader in the field of healthcare imaging.

Samsung is a growing presence in the radiology field and is committed to delivering fast, easy and accurate imaging solutions to healthcare providers. In 2015, NeuroLogica became the US headquarters for all of Samsung Health and Medical Equipment. The full range of Samsung imaging solutions includes Ultrasound, Digital Radiography, and mobile Computed Tomography (mCT). Samsung aims to become a global leader in the medical imaging space and is investing heavily in developing innovative, advanced imaging technologies that will improve the quality of people's lives.

Samsung keeps a constant eye on the always-evolving, ever-changing imaging industry. By continually enhancing current product lines and seeking to develop new technologies, Samsung is at the forefront of the imaging frontier.

ROLE DESCRIPTION:

Responsible for managing product based regulatory activities of a medical device company that designs, manufactures, sells, and services medical imaging equipment.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned

Manage preparation of regulatory documentation to facilitate the commercialization of new products in the US and internationally

Create and submit 510(k), EU technical files, Canadian Class III applications, and other registration documentation

Work with, and respond to, inquiries from regulatory agencies including FDA, EU Notified Body, CFDA, PMDA, TGA, ANVISA and other national and regional health authorities

Develop and enhance regulatory procedures and processes

Monitor the regulatory environment. Stay abreast of changes in regulations throughout all major international geographies and disseminate new regulations and guidance to members of R&Q, Engineering and Marketing

Maintain dashboard for regulatory approvals for international country license / registration renewals

Review labeling and promotional materials to ensure consistency with regulatory approvals

Interact with Marketing, Engineering, Clinical Affairs, Operations to secure product approvals, clearance and registrations

Provide assistance and expertise during regulatory inspections

Understand and provide input for compliance to various global regulatory requirements, such as 21 CFR 803, 806, and 820, ISO 13485 (2016), RDC ANVISA 16/2013, MDD 93/42/EEC, MDR 2017/745, NMPA, MHLW MO 169

Promote teamwork and collaboration within the regulatory function and with other functional areas

Ability to create regulatory updates for Management Review Meeting

Communicate clearly (written and oral) with other company personnel, vendors, regulatory agencies, auditors, and the customer as required

Work independently with minimal supervision and as part of team

Keep knowledge of all NeuroLogica products up-to-date

Attend/complete all required trainings

Follow all company policies regarding travel, expenses, meetings, and meals

Manage time effectively; prioritize and make good business judgments and decisions in relationship to efficiency, effectiveness

Required to wear dosimeter when in direct contact with radiation emitting devices

EDUCATION & EXPERIENCE

Bachelor’s in Engineering or other related discipline

Excellent written, oral, and documentation skills

3+ years’ regulatory experience in the following areas preferred:

Proven record of successful submissions to FDA of 510(k)s

CE Marking and other international registrations

Post-market regulations and requirements for medical devices

Working with devices involving CT, X-Ray and Ultrasound

Ability to communicate effectively with engineers, suppliers, and management through all media (in person, written, electronic – email, skype, and via telephone)

Technically savvy; must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire

COMPUTER SKILLS

Must be able to assemble facts from various areas, analyze data, and provide informed recommendations to management

Must be able to work with minimal supervision, take charge of projects, and work effectively in a demanding, fast paced environment

Must be excellent with technology, be able to present using a laptop computer, and be able demonstrate proficiency with MS Office package, including Excel, Word, and PowerPoint; as well as Outlook, Internet Explorer and Google Chrome

PHYSICAL REQUIREMENTS

Occasionally lift and /or move up to 25 pounds

Frequently required to sit; use hands to finger, handle, or feel; reach with hands; and talk or hear

Must be able to sit for long periods of time

The noise level in the work environment is usually mild

Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus

Interaction with x-ray devices; for this reason strict safety and tracking programs are in place, requiring the utilization of dose monitoring equipment either full time or as necessitated by situation

COMPETENCIES

High attention to detail and a capacity to follow specific, detailed instructions or requirements

Understanding of terminology and ability to share and communicate effectively within the group

Ability to organize and prioritize tasks resulting in consistent productivity

Ability to function within and support a team environment and build strong working relationships

Dependable and punctual

Ability to meet accuracy and productivity goals

Good problem solving skills, ability to evaluate situation and prioritize factors in decision making

Self-motivated, utilize available resources for self-improvement and development

Flexible: able to follow directives and accomplish tasks outside of normal duties

About NeuroLogica

Located North of Boston in Danvers, MA, NeuroLogica Corporation, a subsidiary of Samsung Electronics, develops, manufactures and markets innovative medical imaging equipment for healthcare facilities and private practices worldwide. As a fast-moving, entrepreneurial company, NeuroLogica is a rapidly growing presence in the radiology field and is committed to delivering fast, easy and accurate imaging solutions to healthcare providers. We welcome you to learn more at: https://www.neurologica.com .

We offer a comprehensive benefit package which includes;

6 Different Blue Cross/Blue Shield Medical Plans to meet your needs

Dental coverage through Delta Dental

Vision coverage by VSP

Company paid Short-term and Long-term Disability coverage

$1 for $1 401k match up to 5% managed by Fidelity

Other benefit options such as company paid employee life insurance, a wellness program, tuition reimbursement and many more!

Please contact NeuroLogica if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment." Contact [email protected] for any questions or requests.

NeuroLogica welcomes diversity and is an AA/EEO Employer – Minorities/Women/Veterans/Disabled and other protected categories are always encouraged to apply. The company’s AAP can be made available for inspections upon requests.

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