Regulatory Affairs Associate II

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Regulatory Affairs Associate II

Lower Salford, Pennsylvania

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Full Time Temp to Hire

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NA

Lower Salford, Pennsylvania

Full Time Temp to Hire

NA

March 25, 2024

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Job ID: LS1359581NJN-HR_1711385325

March 25, 2024

Job ID: LS1359581NJN-HR_1711385325

Job Summary

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Position Summary

Manages regulatory process, includes strategy, communication, writing, and/or filing submissions to the U.S. Food and Drug Administration (FDA), Notified Body (CE Mark), and/or Health Canada (Canada) for Class I, Class II, and Class III Medical Devices and Combination products requiring regulatory approval and/or clearance. Coordinates the accumulation of technical information to support regulatory submissions.

Responsibilities

  • Provide regulatory strategy to sustaining product and new product development launch strategy, including documenting testing requirements, submission/registration pathways, and anticipated approval/clearance timelines for defined target markets.
  • Write and submit Investigation Device Exemption (IDE), Premarket Submission 510(k), or Premarket Approval (PMA) submission as appropriate to gain FDA marketing clearance. Write and submission Q-Submissions and/or 513(g) as necessary to support submissions for market clearance. Manage communications and/or meeting with FDA as necessary.
  • Write and maintain Technical File and Design Dossiers as required by EU MDR for CE Marked product(s).
  • Write and submit New License Submissions, Amendments, and Fax Back applications to Health Canada as required for new marketing approval and/or change notifications of existing licenses. Maintain active device listing per MDALL and MDEL as appropriate.
  • Manage all correspondence with FDA, Notified Body, and other regulatory bodies as it associates with regulatory submissions. Organize, file, and maintain all regulatory submissions and related correspondence within department network drive. Ensure easy but permissioned accessibility.
  • Work in partnership with other departments (i.e., engineering, quality, manufacturing, sales, marketing, etc.) as necessary to support regulatory submissions and regulatory compliance.
  • Perform routine regulatory standard and guidance reviews to ensure continued compliance to regulations and standards against the Quality Management System and medical device performance.
  • Participates in change control processes (i.e., design/drawing, specification, labeling, Information for Use, etc.). Review and approve request on behalf of regulatory affairs. Notify distributors, regulatory bodies, and/or other marketing authorization holders of significant changes considered to impact existing registrations, clearances, licenses, etc., as appropriate and the required time. Work with in-country partners to complete notifications, amendments, and re-registrations as required.
  • Support and assist with internal and/or external (Regulatory bodies) Quality Management System audits as required. This may include completing Corrective and Preventative Actions as it related to regulatory processes from an audit finding.
  • Develop, implement, and maintain regulatory affairs department responsibilities, procedures, and processes within our Quality Management System. Provide regulatory training as necessary for continued compliance.
  • Support internal and external regulatory request.
  • Ensure a professional working relationship with internal and external customers to achieve success.

Qualifications

  • Bachelor's degree (B. A./B.S.) from four-year college or university and/or 3+ years related experience and/or training, or equivalent combination of education and experience, or Master's degree (M.S.) in regulatory affairs/science and with 2+ years of relate experience and/or training, or equivalent combination of education and experience.
  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.
  • Ability to apply advanced mathematical and statistical concepts. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • To perform this job successfully, an individual should have knowledge of Database software; Internet software; Inventory software; Manufacturing software; Spreadsheet software and Word Processing software.
  • RAC certification is preferred.
  • Knowledge of Lean Manufacturing and Six Sigma are preferred.
LS1359581NJN-HR_1711385325

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™