Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

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

• 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, and maintains technical documentation compliant with EU 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 along with technical expertise to implement regulatory strategies for new product clearance globally.
• Complies and maintains regulatory documentation 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, and state-of-the-art expectations; assesses impact to existing products, procedures, technical documentation, and market authorizations; and drives implementation plans as assigned.
• Participates in and presents as a Subject Matter Expert in internal audits, external audits, Notified Body audits, regulatory inspections, and technical documentation reviews, including preparation of responses and supporting evidence.
• Maintains and improves regulatory processes, work instructions, templates, and quality system documentation to support compliant, efficient, and consistent regulatory deliverables.
• Reviews and approves labeling, promotional materials, product documentation, and change records to ensure compliance with applicable regulatory requirements, approved indications, market authorizations, and internal procedures.
• Supports post-market regulatory activities, including vigilance or MDR assessment support, complaint trend evaluation inputs, PMS/PMCF documentation inputs, regulatory reporting assessments, and maintenance of regulatory files and databases.
• Maintains current knowledge of applicable Quality Management System requirements and follows all work, quality, and document control procedures to ensure training fulfillment, data integrity, traceability, and high-quality work.

Knowledge, Skills, and Abilities

• Advanced knowledge of medical device regulatory requirements, including ISO 13485, FDA 21 CFR 820/QMSR, EU MDR 2017/745, MDSAP, UDI requirements, and applicable international regulatory frameworks.
• Strong working knowledge of design controls, engineering change control, document control, risk management, verification and validation, labeling controls, technical documentation, and product lifecycle management practices.
• Demonstrated ability to independently support engineering product design projects and translate design, test, risk, clinical, labeling, and manufacturing information into clear regulatory conclusions and audit-ready documentation.
• Technical competency in one or more specialty areas such as biocompatibility, sterilization, packaging or shelf-life validation, process validation, test method validation, software validation, usability, electrical safety, EMC, or cybersecurity documentation.
• Ability to interpret complex regulations, standards, guidance documents, technical reports, test data, and scientific literature and apply them to practical regulatory strategy and compliance decisions.
• Strong technical writing skills with the ability to create clear regulatory assessments, submission content, technical documentation narratives, standards rationales, and responses to regulator or Notified Body questions.
• Ability to lead cross-functional discussions, influence without direct authority, resolve ambiguous regulatory questions, and communicate regulatory risk and options to technical and business stakeholders.
• Strong project management, prioritization, and organizational skills with the ability to manage multiple complex projects and time-sensitive deliverables without loss of accuracy or urgency.
• High attention to detail, sound judgment, professional discretion, and ability to maintain confidentiality of technical, regulatory, and commercial information.
• Ability to maintain a professional, courteous, collaborative, and positive demeanor in all situations.

Education, Training, and Experience

• Bachelor's degree in engineering, biomedical science, life science, regulatory affairs, or related field and at least seven years of progressive regulatory affairs experience in the medical device regulated industry, including direct support of product development or engineering change projects; or
• Associate degree in a related field and at least ten years of progressive regulatory, quality, engineering, or product development experience in the medical device regulated industry, including direct regulatory support of product development or engineering change projects.
• Experience authoring, reviewing, or maintaining EU MDR 2017/745 technical documentation and supporting evidence is required.
• Experience supporting regulatory submissions, regulatory assessments, technical files, design control documentation, or market authorization maintenance for medical devices is required.

Preferred Experience

• Certified Regulatory Affairs Professional (RAC - Devices)
• Certified Project Manager or demonstrated project leadership experience
• Lean Six Sigma Green Belt or Black Belt
• Experience with Class I or Class II medical devices, sterile or patient-contacting devices, electrically powered devices, software-containing devices, or devices requiring specialized verification and validation evidence.
• Experience interacting with FDA, Notified Bodies, authorized representatives, importers, distributors, or international regulatory agencies.