Regulatory Affairs Specialist

Found in: Whatjobs IN C2 - 2 weeks ago

india Hi-Quality Recruits Full time
Job Description
We are seeking a Regulatory Affairs Specialist to support a leading medical device company in Ithaca, NY. 
This is an onsite role open to local candidates. 

Job Summary:
This position will support worldwide regulatory registrations for our current and future medical devices as well as support process compliance in conjunction with our engineering, regulatory and quality departments.
Key Responsibilities:
  • Remain current on all applicable regulatory guidances that impact the company’s ability to legally market medical devices around the world and assist in updating relevant SOPs based on those changes.
  • Remain current with all mandatory and recommended certifications, processes, and applicable standards as they relate to global regulatory compliance and assist in updating relevant SOPs based on those changes.
  • Assist in the creation of regulatory documentation in conjunction with the Engineering team that can be used to support FDA, EU and other worldwide regulatory submissions.
  • Support the company during audits with regulatory agencies or notified bodies.
  • Support registration activities with our distribution channels through creation and provision of the applicable regulatory documents and filings.
  • Maintain documentation and certifications for all country-based registrations.
  • Create gap analyses and remediation plans for identified gaps when standards are updated and drive project teams to fulfill those remediation plans.
  • Review Marketing Communications, Instructions for Use and other technical documentation to ensure they comply with regulatory claims standards.
  • Perform training on regulatory procedures and updates on guidances to company personnel.
  • Facilitate the Risk Management Process in compliance with applicable external standards and corporate policies.
  • Work with the Engineering team to develop usability test plans and human factors testing that meets the various EU and US standards.
  • Aid in post market surveillance for our various devices.

Requirements
Education: 
  • Bachelor’s degree in engineering (Biomedical, Chemical, Mechanical, Software/Computer, Electrical), science, or technical discipline with coursework in Regulatory Affairs/Quality Engineering
Required:
  • 0-3 years of experience in medical device engineering/medical device regulatory affairs.
  • Must be accurate in handling detailed information/data.
  • Strong ethics and be diligent in follow up on multiple projects.
  • Quick learner with the ability to learn about various product lines and how they function.
  • Proficient in Microsoft Suite products.

Preferred:
  • Knowledge of ISO 13485, MDD 93/42/EEC and MDR 2017/745, domestic FDA and international regulatory requirements, medical device registrations, design control activities for medical devices.
  • Experience with FDA and Notified Body inspections.
  • Experience with Class II (US)/Class I, Class II and Class III (Europe) medical devices.
  • Ability to handle multiple tasks simultaneously and ability to manage project timelines, read and interpret complex engineering and mechanical drawings and documentation, and interpret FDA and foreign regulatory guidance as it relates to medical devices and medical devices containing software

Benefits
  • Health benefits
  • PTO
  • Holidays
  • Retirement benefits
  • Career advancement opportunities
  • Friendly work environment
  • And more

The anticipated base pay range for this position is $69,000 to $75,000. This range may be modified in the future and actual compensation may vary from posting based on geographic location, work experience, education and/or skill level. Employees may be eligible to participate in company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal, and family time off in accordance with the terms of the applicable plans.
An equal opportunity employer and we value diversity at our company. All aspects of employment are based on merit, performance, and business needs. We do not discriminate based upon race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
For more information about Hi-Quality Recruits, please visit
Required: 0-3 years of experience in medical device engineering/medical device regulatory affairs. Must be accurate in handling detailed information/data. Strong ethics and be diligent in follow up on multiple projects. Quick learner with the ability to learn about various product lines and how they function. Proficient in Microsoft Suite products. Preferred: Knowledge of ISO 13485, MDD 93/42/EEC and MDR 2017/745, domestic FDA and international regulatory requirements, medical device registrations, design control activities for medical devices. Experience with FDA and Notified Body inspections. Experience with Class II (US)/Class I, Class II and Class III (Europe) medical devices. Ability to handle multiple tasks simultaneously and ability to manage project timelines, read and interpret complex engineering and mechanical drawings and documentation, and interpret FDA and foreign regulatory guidance as it relates to medical devices and medical devices containing software

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