Senior Regulatory Affairs Specialist

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Full Time Professional Columbia, SC, US

Salary Range: $ To $ Annually

The Senior Regulatory Affairs Specialist is responsible for independently supporting Rhythmlink Regulatory Affairs in the development, implementation, and maintenance of domestic and international medical device regulatory compliance activities. This role serves as a senior individual contributor and regulatory subject matter expert for new product development, design changes, and lifecycle management activities, with emphasis on independent support of engineering product design projects, regulatory strategy, technical documentation, and technical areas such as biocompatibility, sterilization, packaging, labeling, process validation, test method validation, software validation, and verification and validation evidence.

Success in this role is measured by timely and high-quality regulatory deliverables, audit-ready technical documentation, effective cross-functional regulatory leadership, maintenance of global market authorization, and support of compliant product commercialization and lifecycle management.

Essential Functions

(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills, and other characteristics. This list of tasks is not a comprehensive listing of all functions and tasks performed by this position. It does not imply that this position performs all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)

• Regulatory Lead for assigned new product development, sustaining engineering, and product lifecycle projects, independently advising cross-functional teams on regulatory requirements, submission strategy, technical evidence needs, and market authorization impact.
• Builds, authors, reviews, andmaintainstechnical documentation compliant withEU MDR 2017/745, including Annex II and Annex III documentation, GSPR evidence, risk management linkages, clinical and post-market surveillance inputs,clinical evaluation, verification and validation summaries, and technical rationale for conformity assessment.
• Applies regulatory strategic thinking alongwith technicalexpertiseto implement regulatory strategies for new product clearance globally.
• Compliesandmaintainsregulatorydocumentation for market access including U.S.510(k) premarket submissions, EU technical documentation, Canadian licenses, and international registrations, amendments, supplements, renewals, and responses to regulatory or Notified Body questions.
• Independently evaluates design changes, manufacturing changes, supplier or material changes, labeling changes, and product line extensions for regulatory impact, including significant change assessments and the need for notifications, submissions, technical documentation updates, or market-specific actions.
• Provides regulatory input to engineering design controls, including design inputs, user needs, risk management, verification and validation planning, standards strategy, usability, labeling, design transfer, and objective evidence needed to support regulatory submissions and technical documentation.
• Serves as a regulatory subject matter expert for technical areas such as biocompatibility, sterilization, cleaning or reprocessing where applicable, packaging and shelf-life, process validation, test method validation, software validation, cybersecurity or software documentation where applicable, electrical safety, EMC, and other product-specific standards or evidence needs.
• Reviews protocols, reports, risk assessments, scientific rationales, product specifications, drawings, labeling, supplier documentation, validation documentation, and other technical records for regulatory adequacy, consistency, traceability, and audit readiness.
• Uses scientific and regulatory judgment when interfacing with Engineering, R&D, Quality, Clinical, Operations, and Manufacturing to define appropriate test strategies, acceptance criteria, data packages, and rationales needed to support regulatory conclusions.
• Monitors new and revised regulations, standards, guidance documents, andstate-of-the-art expectations; assesses impacttoexisting products, procedures, technical documentation, and market authorizations; and drives implementation plans as assigned.
• Participates in and presents as a…