Regulatory Affairs/Quality Affairs Specialist

Elliquence•Baldwin, NY

20h•$75,000 - $87,000

About The Position

This role collaborates cross-functionally across the organization to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.

Requirements

Bachelor's degree in biomedical, RA/QA or related scientific area for medical device industry (RAC certification preferred).
3-5 years’ experience in a regulated FDA environment (medical devices or combination products).
Working experience in both Quality and Regulatory preferred.
Hands-on experience with 510(k) submissions (IDE and PMA knowledge a plus).
Strong knowledge in regulatory strategy and approval approaches.
Hands on experience in leading or partnering in CAPA, SOP, RMA, NCR, Safety Reporting and investigations.
Strong understanding of FDA and EU medical device regulations (international experience desirable).
Ability to efficiently navigate through the regulatory process either individually or in a team setting ensuring a project’s success.
Strong organizational, communication (verbal and written), and planning skills.
Ability to interact cross functionally across multiple departments with various levels of the organization.
Detail oriented, practical and proactive problem solver.
Proficiency with PC systems and office applications.
Solid understanding of scientific principles applied to regulatory affairs.
Understanding of regulatory and business needs with ability to engage cross functional team members.

Nice To Haves

RAC certification preferred.
Master’s degree in related field can count towards 1 year of relevant experience.
Working knowledge of FDA, EU MDR, or ISO regulatory environments preferred.
Audit experience as a contributor is preferred.

Responsibilities

Author and manage (under leadership’s supervision) the preparation, formatting, and collection of regulatory submissions
Ensure the maintenance of regulatory files, declarations of conformity, and device listings/registrations are accurate and complete.
Oversee inquiries into regulatory agency requests for additional information for document submission.
Support U.S. and EU market approval processes and ensure compliance with regulatory standards
Oversee post-market product safety surveillance, data trending, and risk management processes for commercial medical devices.
Analyze and report post-market quality data/metrics and failure trends to identify safety signals.
Support post-market submissions (progress reports, annual reports, etc.)
Serves as site lead on RMA and NCR’s and escalates to leadership on metrics and complex concerns for resolution.
Provide regulatory and quality assessments for marketing, R&D, and manufacturing changes or product transfers.
Communicate with distributors in response to requests for information, regulatory inquiries or in support of regulatory filings.
Partner with Quality Assurance to ensure continued compliance with applicable regulatory standards, including but not limited to FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745.
Support in audits (internal and external) in document preparation as needed.
Partner with Quality in driving Corrective and Preventive Actions (CAPAs) related to post-market findings.
Leads or supports problem-solving and root cause analysis activities, as needed. Coaches cross-functional teams as a problem-solving subject matter expert.
Support document control and recordkeeping to ensure regulatory documentation integrity and traceability.
Assist in preparing regulatory applications that are compliant with applicable regulatory requirements to achieve business objectives.
Partners cross functionally across the organization to gather information required for submissions and documentation.
Lead or partner in regulatory documentation including but not limited to writing summaries, tracking progress on deliverables, and ensure timely submission of documents.
Support training and awareness initiatives related to regulatory compliance.
Interpret new or existing regulations and ensure business practices align with compliance requirements.
Create documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance.
Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to other teams/departments and executive leadership.
Establish and maintain regulatory information systems.
Contributes in the continuous improvement initiatives and process optimization within Regulatory Affairs and Quality Affairs.