Regulatory Affairs Specialist III (Plano, TX)
- Regulatory Submissions and Compliance:
- Develop regulatory strategies to achieve market clearance in an effective and efficient manner
- Prepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU and other regulatory requirements as applicable
- 510(k) and/or De Novo submissions for FDA
- Technical documentation for EU MDR compliance
- International product registration activities to meet business objectives
- Provide regulatory input to support product labeling
- Monitor new and changing regulatory requirements and ensure the business understands relevant impacts
- Lead corrective and preventive action (CAPA) efforts as assigned
- Product Development Support:
- Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions
- Change Control Management:
- Assess and document regulatory impacts of design changes, manufacturing changes, et al, including related 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 continuous improvement activities
- Supporting Lean and Kaizen initiatives
- Comply with all company policies and procedures
- Assist with any other duties as assigned
- Education: Bachelor of Science degree
- Experience: 5-7 years of regulatory affairs experience in medical device industry, preferably with respiratory devices. Current experience leading multiple successful 510(k) clearances and CE marking is required, and experience with additional global regulatory pathways is preferred
- 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 Microsoft Excel skills for reporting and analysis. Understanding of continuous improvement principles.
- Personal Attributes:
- Strong verbal and written communication skills, with the ability to articulate complex technical issues clearly and effectively to cross-functional teams and regulatory bodies.
- Strong analytical and critical thinking skills, with the ability to resolve complex complaints and implement long-term solutions.
- High level of attention to detail and accuracy, particularly when preparing regulatory submissions
Recommended Jobs
Part-Time Client Services Professional
Join Texas First Bank! Enjoy a generous Sign-On Bonus and Retention Bonus as a thank-you for your commitment. Founded in 1973, Texas First Bank is a fast-growing community bank with 27 locations acr…
Caregiver
Are you looking for a new best friend, card-game companion, or gardening guru? Then consider working with one of our light, bright, and beautiful Assisted Living and Memory Care communities - where ou…
Sr Design Verification Engineer ( Remote)
Sr Design Verification Engineer Location: Remote (Anywhere in USA) Full-time: Salary + Benefits + Bonuses / Contractor Work Status: US Citizen Role & Responsibilities Verification of ASIC…
AWS Engineer
The R&D DevOps Engineering role is responsible for the hands-on development and support of cloud native technologies. The engineer will work with both business and technical teams to design cutting ed…
Consultor de viajes independiente
Construye tu carrera desde casa o otro lugar en Estados Unidos o Latinoamerica ¿Te apasiona el mundo de los viajes y sueñas con una carrera flexible que te permita trabajar a tu ritmo? Esta es t…
Social Media Manager
Overview: Social Media Manager The Social Media Manager plays a key role in driving brand awareness and customer engagement across multiple restaurant concepts. This position is responsible for…
NP/PA - Emergency Medicine
JOB OVERVIEW • Job Title: Nurse Practitioner / Physician Assistant – Emergency Medicine (AP) • Job Type: Locum Tenens • Location: Eagle Pass, TX • Service Setting: Inpatient | Emergency Depart…
Financial Services Tax - Real Estate Senior Associate Save for Later Remove job
A career in our Financial Services Tax practice, within Corporate Tax services, will provide you with the opportunity to help our clients meet their tax obligations while managing the impact tax ha…
Calypso Analyst (Boston, MA; Merrimack, NH; Newark, NJ; Westlake, TX)
The Role ~ We are looking for a forward-looking self-starter who thrives in a fast-paced environment. This individual must combine their validated ability to collaborate and customer focused mental…