Position Overview: The Regulatory Affairs Associate will support the regulatory functions for a global medical device company. This role involves ensuring that the company’s products meet the regulatory requirements for various international markets, including the United States, Europe, and other regions. The individual will work closely with product development, quality assurance, and other teams to ensure compliance with applicable regulations and standards.

Key Responsibilities:

• Regulatory Submissions:
• Assist in preparing and submitting regulatory filings for medical devices, including 510(k) submissions, CE Marking, and other international regulatory submissions.
• Prepare, compile, and submit regulatory documents to regulatory agencies (e.g., FDA, EMA, Health Canada, TGA, etc.).
• Ensure timely preparation and submission of regulatory documentation in accordance with agency requirements and company timelines.
• Compliance Management:
• Maintain up-to-date knowledge of medical device regulations, guidelines, and standards (e.g., FDA 21 CFR, ISO 13485, MDD/MDR, etc.).
• Assist in ensuring ongoing compliance with applicable regulatory requirements for manufacturing, labeling, and post-market activities.
• Support internal or external audits and inspections related to regulatory compliance.
• Product Registration:
• Support product registrations in various global markets, ensuring compliance with country-specific regulatory requirements.
• Assist with obtaining and maintaining regulatory approvals and licenses for all medical devices marketed and sold globally.
• Labeling and Documentation:
• Assist in the review and approval of product labeling, including packaging, instructions for use (IFU), and promotional materials, to ensure they comply with regulatory requirements.
• Maintain up-to-date product regulatory files, ensuring all documentation is current, accurate, and readily available for regulatory inspections or audits.
• Post-Market Surveillance:
• Assist in the collection, evaluation, and reporting of post-market data to regulatory authorities as required (e.g., adverse event reporting, recalls, safety notices).
• Support the management of vigilance systems to ensure regulatory reporting requirements are met and assist in root cause analysis for any post-market issues.
• Cross-Functional Collaboration:
• Collaborate with R&D, Quality Assurance, and Manufacturing teams to ensure products meet regulatory standards throughout the lifecycle.
• Provide regulatory guidance during the design and development phases of new medical devices, ensuring that regulatory requirements are considered from the start.
• Regulatory Intelligence:
• Monitor and analyze global regulatory changes and trends, and communicate key regulatory developments that may impact the company’s products or strategies.
• Assist in the preparation of regulatory reports to senior management on the status of filings, approvals, and market access.

Qualifications:

• Education: A Bachelor’s degree in Life Sciences, Engineering, or a related field. Regulatory Affairs certification (e.g., RAC) is a plus.
• Experience:
• 1-3 years of experience in regulatory affairs, ideally within the medical device industry.
• Familiarity with FDA and European Union regulations for medical devices (21 CFR 820, ISO 13485, MDD/MDR, etc.).
• Experience preparing and submitting regulatory filings such as 510(k), CE Marking, and other international submissions.
• Skills:
• Strong understanding of regulatory requirements for medical devices in global markets (U.S., EU, Canada, etc.).
• Excellent written and verbal communication skills, with the ability to prepare clear and concise regulatory documents.
• Detail-oriented, with strong organizational skills and the ability to manage multiple projects simultaneously.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and as part of a cross-functional team.
• Knowledge of electronic document management systems (EDMS) is a plus.

Additional Requirements:

• Strong analytical and problem-solving skills.
• Ability to thrive in a fast-paced environment and adapt to changing priorities.
• Understanding of medical device lifecycle management, from development to post-market.
• Willingness to travel domestically or internationally as required for regulatory inspections or meetings.

Working Conditions:

• The role will be based in the company’s headquarters.
• Occasional travel may be required for regulatory inspections, conferences, or meetings.

Location:

Baldwin, NY

Job Type: Full-time

Pay: $65,000.00 - $75,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Weekends as needed

Application Question(s):

• How many years of Regulatory Affairs do you have?

Ability to Commute:

• ​​​​​​​ In person
• Baldwin, NY 11510 (Required)

Ability to Relocate:

• Baldwin, NY 11510: Relocate before starting work (Required)

As a global company, elliquence educates physicians on the least invasive procedural solutions for spine pathology and provides our unique and specialized tools to support these procedures. The procedures are truly the least invasive solutions available today, and generally begin with targeting the spinal anatomy with a spine needle. Our tag line, “Less is More” is the absolute truth.

What we offer:

Base salary and annual performance-based bonus.
Medical, dental, vision and life insurance
401(k)