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Samsung Electronics America Regulatory Affairs Specialist in Danvers, Massachusetts

Regulatory Affairs Specialist

Location:

Danvers, MA

Job Id:

522

# of Openings:

1

Regulatory Affairs Specialist

Please Note: Projected Start Date January 2021

Take a walk around our Danvers, MA Headquarters and you’ll see a dedicated group of professionals who care about improving health care – that quite literally saves lives each and every day. We are extremely honored to be one of only a few companies in the world that manufacture CT scanning equipment which is used for infectious disease screening.

What about our company values and culture? Our team is aligned on our core values which includes individual responsibility, respect, hard work and always maintain a sense of urgency – for literally lives are being saved each and every day as a result of the efforts of our collaborative team.

We thrive on collaboration and sharing ideas, whether in a cross-functional meeting or at one of our office events. While we're diverse in our backgrounds and skills, we have much in common. A passion for our mission. A strong sense of integrity. A belief that we're making an impact on the ever-changing technology in healthcare. Come be a part of something quite remarkable!

NeuroLogica is on the front lines to help combat the Coronavirus! Check out this recent news segment on NBC: https://lnkd.in/gHzkbjS

SUMMARY: Responsible for managing post market surveillance activities and regulatory functions for 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 all stages of complaint documentation (review, coordination, investigation, tracking, reporting, closure) and post market surveillance reporting globally (includes MDRs)

  • Manage Post Market Surveillance Reporting metrics; assist in relaying metrics to management

  • Expedite investigations by collaborating with internal/external business partners

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

  • Help develop and enhance regulatory procedures and processes

  • Plan, execute, monitor, and bring to closure all field safety corrections and recalls

  • Maintain Post Market Surveillance documentation for EU MDR (PSUR, PMCF, etc.)

  • Assist in searching for literature documentation and help compile information for Clinical Evaluation Reports

  • Manage labeling and unique device identification requirements

  • Other project support for developing regulatory systems and training others

  • Help maintain database of global regulatory listing and approvals

  • Assist preparation of global regulatory submissions, and maintain technical files / design dossiers

  • Participate in ship reviews to ensure equipment follows the approved documentation and regulations

  • Interact with Quality, Marketing, Engineering, Clinical Affairs, Operations for creating product specific documentation

  • Assist during FDA, ISO, MDSAP and other audits

  • 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

QUALIFICATIONS: 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 & Experience

  • Bachelor’s in Engineering / Nursing or other related discipline preferred

  • Excellent written, oral, and documentation skills

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

  • 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 & Analytic 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

  • 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 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!

NeuroLogica welcomes diversity and is an AA/EEO Employer – Minorities/Women/Veterans/Disabled and other protected categories are always encouraged to apply.

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