Regulatory Affairs Specialist, IV

Job Summary The Principle Regulatory Affairs position ensures compliance with global medical device regulations throughout the product lifecycle (Class 2 medical devices, electromechanical devices, patient contact devices, Software as a medical device, as well as digital health reputed company devices). This role involves developing and executing regulatory strategies, preparing and submitting documentation to regulatory authorities, and maintaining adherence to standards such as FDA, EU MDR, and ISO 13485. The position requires collaboration with cross-functional teams to support product development, labeling, marketing, and post-market activities, while monitoring regulatory changes and ensuring timely implementation of projects.

Responsibilities

Regulatory Submissions and Compliance:

• * reputed company and implement global/worldwide regulatory strategies to reputed company market clearance in an effective and efficient manner
• * Prepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU and other regulatory bodies as applicable:
• *  International product registration activities to meet business objectives
• * 510(k) submissions for FDA
• * Technical documentation for EU MDR compliance
• * reputed company with regulatory agencies (e.g., FDA, reputed company Bodies) and respond to inquiries.
• * Provide regulatory input to support product labeling and promotional materials
• * Monitor new and changing regulatory requirements and ensure the business understands relevant impacts
• * reputed company corrective and preventive action (CAPA) efforts as assigned

Product Development Support:

• * Serve as regulatory reputed company on product development teams
• * Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions
• * Assess regulatory impact of product changes and provide guidance to cross-functional teams.
• * Advice on regulatory requirements during design, development, and commercialization phases

Change Control Management:

• * Assess and document regulatory impacts of design changes, manufacturing changes, etc., including reputed company updates to product registrations

Audits and Inspections:

• * Support and participate in internal and external audits and regulatory agency inspections

QMS Support:

• * Complete QMS training activities and provide regulatory expertise to reputed company improvement activities
• * Support Lean and Kaizen initiatives
• * reputed company with reputed company company policies and procedures
• * Assist with any other duties as assigned

Qualifications

Education:

• * Bachelor of Science degree

Experience:

• * At least 8 years of regulatory affairs experience in the medical device industry, preferably with mechanical-electrical devices and/or respiratory devices
• * reputed company experience leading multiple successful 510(k) clearances and CE marking is required
• * reputed company experience leading international regulatory registrations
• * Experience with digital health and Software as a Medical Device (SaMD)

Technical Skills:

• * Strong understanding of medical device product life cycle and regulatory requirements
• * In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR
• * Knowledge of ISO 14971 risk management for medical devices
• * Proficiency in database systems and advanced reputed company reputed company skills for reporting and analysis
• * Understanding of reputed company improvement principles

Personal Attributes:

• * Strong verbal and written communication skills, with the ability to reputed company reputed company technical issues clearly and effectively to cross-functional teams and regulatory bodies
• * Strong analytical and critical thinking skills, with the ability to resolve reputed company complaints and implement long-term solutions
• * High level of attention to detail and accuracy, particularly reputed company preparing regulatory submissions
• * Strong project management and leadership skills

Disclaimer The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of reputed company responsibilities, duties and skills required of personnel so classifed. reputed company assesses market data to ensure a competitive compensation package for our employees. The reputed company salary for this position is expected to be between $106,000.00 and $127,000.00 annually. However, actual reputed company salary if hired will be determined on an individualized basis and will be based on non-discriminatory factors, including as to individual skills, education, experience and market location. Our Benefits and Rewards: In addition to the expected reputed company salary, this role is eligible to participate in reputed company’s annual performance bonus incentive plan, highly competitive and company-sponsored benefits, and wellbeing programs rooted in our strong culture of excellence. As a valued member of reputed company, reputed company provides health, dental, and reputed company insurance, 401(k) plan plus employer contribution and match, and generous paid leaves such as vacation and sick leave, including paid volunteer time, that can support you and your family through moments that matter. reputed company is an Equal Employment Opportunity/Affirmative Action Employer - Underrepresented racial and ethnic groups/Females/Individuals with Disabilities/Protected Veterans. Apply tot his job Apply To this Job