Senior Specialist, Regulatory Affairs and Compliance

Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment.

Summary of the role

As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.

Summary

Provides regulatory guidance to product development teams on strategic planning to support optimal timelines for product launches. Under minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and Technical Files. Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. Helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams. The role assists in the development of best practices for Regulatory Affairs process.

Duties and Responsabilities

• Prepares regulatory strategies and maintains submissions for U.S. and International markets, including but not limited to 510(k)s and Technical Files, to ensure timely approval of devices and continued regulatory support of marketed devices.
• Reviews and summarizes post-market surveillance feedback, such as customer feedback, adverse event reporting, customer surveys, trade shows, and publications.
• Evaluates and documents all alleged reportable events and field action reviews/assessments. Prepares and submits all MDRs and associated documentation to the FDA and adverse event reports to other countries within the required timeframes. Follows-up, as required, for failure investigations associated with reportable events. Interacts with the FDA and other regulatory authorities on all MDR or reportable events.
• Maintains and prepares device registrations, listings, certifications, export certificates, and Declarations of Conformity.
• Responsible for understanding and complying with current domestic and international regulatory requirements, including but not limited to FDA, European, and Canadian requirements.
• Acts as a Regulatory Affairs representative on core product development teams. Communicates regulatory requirements and impact of regulations to the development teams. Reviews design history files to ensure all regulatory requirements are being met.
• Reviews and provides regulatory authorization for labeling, marketing literature, and protocols/ reports for compliance with regulatory requirements.
• Evaluates, investigates, documents and communicates with both the FDA and/or other regulatory authorities on all product recalls. Writes all recall communications to the field and customers. Documents and reconciles product inventory associated with recall. Follows up with corrective action associated with recall issue.
• Provides oversight of third party testing (UL, EMC, biocompatibility, sterilization assurance) as required.
• Manages of executes a timely and effective internal audit program. Reviews processes for compliance to appropriate regulations and internal procedures.
• Provides support for external audits conducted by Quest customers, regulatory authorities, and Notified Bodies

Qualifications

• Bachelor of Science degree in a relevant discipline required.
• Minimum five years of experience in medical device Regulatory Affairs, four years in medical device Class II/III is required. Candidates with 2+ years of practical experience in the regulated medical device industry may be considered if they possess and advanced degree in Regulatory Affairs or other related discipline.
• Demonstrated knowledge of FDA QSR, ISO13485, MDD, Health Canada, and other applicable U.S. and International regulations. Knowledge of Japanese, Australian, and Brazilian requirements preferred.
• Expertise in FDA Quality System Regulation, ISO13485, CMDR, MDD, and ISO 14971, including experience auditing to these requirements. Experience with IEC 60601 preferred.
• Experience with preparing and filing reportable events (MDRs) and Vigilance Reports.
• Previous experience with FDA regulatory submissions and CE marking.
• Experience interacting with regulatory bodies, such as the FDA and Notified Body.
• Experience with the UL certification process.
• Excellent prioritizing, organizational, and interpersonal skills. Ability to handle multiple projects simultaneously.
• Must possess technical writing, project management and fundamental problem-solving skills.
• Ability to review and provide critical feedback on design documentation.
• Excellent writing and communication skills. The individual should be detail-oriented and have good deductive and problem solving skills. Due to the requirements of a quality assurance environment, a certain degree of initiative and good mechanical aptitude would be advantageous.
• RAPS RAC (US) strongly preferred.
• ASQ certification as a Certified Quality Auditor (CQA) preferred.

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Interested?

If you are interested in being a part of a team and creating an inclusive and diverse workplace, please apply online with your CV.

About Nordson Medical

At Nordson MEDICAL, you don't have to be a doctor to help save lives. We are the global expert in the design, development, and manufacturing of complex medical devices and component technologies. By joining our team today, you will help us bring innovative ideas to life. Nordson MEDICAL is a global team that works to create components for life-saving medical devices. We offer a supportive culture in a growing and dynamic work environment. Whether you're just beginning your career or you're a seasoned professional, there's a place for you to belong at Nordson MEDICAL. We offer hourly and salary positions in production, maintenance, customer service, quality, engineering, and more. We actively invest in our teams to help you build your skillsets and advance your career.