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Nordson Corporation · 2 days ago

Manager, Regulatory Affairs and Compliance

Allen, TX

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

Nordson Corporation is committed to developing and maintaining a comprehensive Quality & Regulatory Affairs system. The Manager of Regulatory Affairs and Compliance will lead the regulatory and document control teams, ensuring compliance with medical device regulations and overseeing submissions for product approvals.

IndustrialManufacturingPackaging ServicesTest and Measurement

Responsibilities

Manages the personnel activities of the Regulatory Affairs and Document Control departments, including recommendations related to resource needs, training, and personnel development. Provides feedback on staff performance via performance reviews, and mentorship to continually improve staff skills and effectiveness

Reviews and assesses changes to global regulatory requirements and industry best practices, and facilitates implementation through new or revised Quality Systems processes

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

Provides technical guidance and instruction to staff in relation to regulatory affairs and document control policies and procedures

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, Canadian, Australian, Japanese, and Brazilian 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

Allocated resources to ensure department priorities are realized and budget goals are met

Provides oversight of third party testing (UL, EMC, biocompatibility, sterilization assurance) as required

Supports an effective internal audit program. Reviews processes for compliance to appropriate regulations and internal procedures

Provides support for external audits conducted by Quest customers and regulatory authorities

Oversees document control efforts to ensure compliance with domestic and international regulations and standards

Contributes to the development and implementation of business operating plans

Evaluates and implement new document control systems

Qualification

Regulatory AffairsFDA QSRISO 13485Project ManagementRAPS RAC CertificationASQ CQA CertificationTechnical WritingInterpersonal SkillsProblem-Solving Skills

Required

Bachelor of Science degree in a relevant discipline required

Minimum ten years of experience in medical device Regulatory Affairs, seven years in medical device Class II/III required. Candidates with 5+ years of practical experience in the regulated medical device industry may be considered if they possess an advanced degree in Regulatory Affairs or other related discipline

Minimum 5 years of experience with project management

Expertise in FDA QSR, ISO13485, EU MDR, Health Canada, and other applicable U.S. and International regulations, including experience auditing these requirements

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