Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for assisting Meridian with its regulatory and quality processes, including the product realization process, ensuring that all activities align with relevant quality and regulatory standards, particularly in the design, development, and manufacturing of medical devices.

• Support the regulatory team in achieving product compliance throughout various phases of the product lifecycle, including research, development, transfer, validation/verification, labeling, regulatory submissions, and ongoing lifecycle management.

• Collaborate across departments to guarantee that regulatory guidance is aligned with business goals.

• Offer support and direction for quality and regulatory initiatives, including Design Control activities, project teams, design transfer processes, clinical trials, validation and verification tasks, and modifications to existing products.

• Assist in drafting sections of regulatory submissions for domestic and global commercialization as well as other business targets.

• Compose, assess, and review technical protocols and data supporting clinical trials, validation, verification, and product manufacturing.

• Provide direct assistance concerning adverse events, reportable medical device incidents, and product recall efforts, including corrections and removals.

• Assess the regulatory implications of changes related to product design alterations and regular change control processes.

• Prepare and evaluate product labeling activities, including Instructions for Use (IFU/PI), ensuring compliance with applicable regulations and standards.

• Contribute regulatory insights and oversight to product lifecycle planning, including risk management efforts, and track product lifecycle changes as directed.

• Gather new product technical data and feature summaries to support market expansion initiatives.

• Address inquiries from Sales & Marketing to ensure that collateral and promotional materials adhere to relevant regulations.

• Engage in long-term projects that align with the business and quality objectives of the organization.

• Aid in managing both third-party and internal Quality Audit programs; conduct supplier audits and verification activities as instructed.

⛳️ Requirements

• A Bachelor of Science degree in Biology, Biochemistry, Microbiology, or a related field is required.

• At least 4 years of direct experience in Regulatory Affairs is necessary, including the preparation of Pre-IDEs, 510(k) submissions, EU Technical Files, Canadian Class II and III licenses, STED documentation, and more.

• Previous experience in an FDA/ISO regulated environment; Quality Assurance, Quality Systems, Design Control, Regulatory Affairs, or similar roles.

• Demonstrated knowledge of FDA and ISO regulated settings (Medical Devices, Pharmaceuticals, In Vitro Diagnostic Medical Devices), including risk management principles (e.g., ISO 14971).

• Familiarity with the design, development, and clearance processes for medical devices.

• Proven strong leadership, project management, and organizational abilities.

• Highly driven, detail-oriented, with a constant awareness of customer needs and an aptitude for making informed decisions; maintain precise records and adhere to regulatory and quality system requirements such as 21 CFR 820, ISO 13485, 98/79 EC, and SOR/98-282.

• Must be well-organized with a keen attention to detail, able to prioritize and manage workloads effectively to meet strict deadlines, performing well under pressure in a dynamic environment.

• Capable of adapting to shifting priorities, managing time efficiently, and ensuring that tasks and multiple projects are prioritized and completed punctually.

• Exceptional communication skills (both written and verbal), strong interpersonal skills, problem-solving abilities, and an aptitude for interacting effectively with all organizational levels, both internally and externally.

• Ability to address large groups and actively engage participants.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Professional development opportunities