Samsung Electronics America Regulatory Affairs Specialist in Danvers, Massachusetts
Regulatory Affairs Specialist
# of Openings:
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
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
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
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.
Samsung Electronics America
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