Regulatory Affairs Senior Specialist

2 weeks ago

Danvers, Massachusetts, United States NeuroLogica Full time
WHO WE ARE:
NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., is at the forefront of developing, manufacturing, and marketing cutting-edge imaging technologies. Our commitment lies in providing swift, straightforward, and precise diagnostic solutions to healthcare professionals.

As the global headquarters for mobile computed tomography, NeuroLogica also serves as the US hub for sales, marketing, service, and distribution of all Samsung digital radiography and ultrasound systems. Our state-of-the-art medical technologies are utilized globally in leading healthcare institutions, enhancing patient care, boosting patient satisfaction, and streamlining workflow efficiency.

ROLE DESCRIPTION:
In this role, you will oversee product-specific regulatory activities within a medical device organization focused on the design, manufacturing, sales, and servicing of medical imaging equipment.

KEY RESPONSIBILITIES:
- Lead the preparation of regulatory documentation to support the commercialization of new products both domestically and internationally.
- Create and submit 510(k) applications, EU technical files, Canadian Class III applications, and other necessary registration documents.
- Collaborate with regulatory agencies such as the FDA, EU Notified Body, CFDA, PMDA, TGA, ANVISA, and other national and regional health authorities.
- Develop and refine regulatory procedures and processes.
- Monitor the regulatory landscape and keep the team informed of changes in regulations across major international markets.
- Maintain a dashboard for tracking regulatory approvals for international licenses and registration renewals.
- Review labeling and promotional materials to ensure alignment with regulatory approvals.
- Work closely with Marketing, Engineering, Clinical Affairs, and Operations to secure product approvals and registrations.
- Provide expertise during regulatory inspections and ensure compliance with global regulatory requirements.
- Foster teamwork and collaboration within the regulatory function and across other departments.
- Prepare regulatory updates for Management Review Meetings.
- Communicate effectively with internal teams, vendors, regulatory agencies, auditors, and customers as necessary.
- Operate independently with minimal supervision while also being a team player.
- Stay updated on all NeuroLogica products and complete required training.
- Adhere to company policies regarding travel, expenses, meetings, and meals.
- Manage time efficiently and make informed business decisions to enhance effectiveness.
- Required to wear dosimeter when in direct contact with radiation-emitting devices.

EDUCATION & EXPERIENCE:
- Bachelor’s degree in Engineering or a related field.
- Exceptional written, oral, and documentation skills.
- A minimum of 3 years of regulatory experience in relevant areas is preferred, including:
- Proven success in FDA submissions of 510(k)s.
- CE Marking and other international registrations.
- Knowledge of post-market regulations for medical devices.
- Experience with CT, X-Ray, and Ultrasound devices.
- Strong communication skills to interact effectively with engineers, suppliers, and management across various platforms.
- Technically adept, capable of discussing and making decisions on a wide range of engineering disciplines and complex technical/logistical issues.

COMPUTER SKILLS:
- Ability to gather and analyze data from various sources, providing informed recommendations to management.
- Must work independently, manage projects effectively, and thrive in a fast-paced environment.
- Proficient in MS Office Suite, including Excel, Word, PowerPoint, Outlook, Internet Explorer, and Google Chrome.

PHYSICAL REQUIREMENTS:
- Occasionally lift and/or move up to 25 pounds.
- Frequently required to sit, use hands for various tasks, reach, and communicate.
- Must be able to sit for extended periods.
- Specific vision abilities required include close vision, distance vision, peripheral vision, depth perception, and the ability to adjust focus.
- Interaction with x-ray devices necessitates strict safety protocols and monitoring equipment.

COMPETENCIES:
- High attention to detail and ability to follow specific instructions.
- Strong understanding of terminology and effective communication within the team.
- Ability to organize and prioritize tasks for consistent productivity.
- Team-oriented with the ability to build strong working relationships.
- Dependable, punctual, and capable of meeting accuracy and productivity goals.
- Good problem-solving skills with the ability to evaluate situations and prioritize effectively.
- Self-motivated and proactive in utilizing resources for personal development.

FLEXIBILITY:
- Willingness to follow directives and complete tasks beyond standard duties.

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