Regulatory Affairs Specialist
Posted on :
12-04-2024
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
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 countrybased 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:
- 03 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 $69000 to $75000. 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 HiQuality 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
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
