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Regulatory Affairs Specialist

Company: JALEX Medical, LLC
Location: Cleveland
Posted on: January 16, 2022

Job Description:

Regulatory Affairs Specialist
JALEX Medical is a privately held design, engineering, and product development firm located just west of Cleveland, Ohio. Our team is staffed with full-time biomedical engineers, regulatory affairs specialists, & quality management solutions providers. Our specialty is custom product development for the medical device industry with clients all over the world. JALEX is dedicated to bringing innovation to market and has developed complex medical devices for a variety of surgical specialties such as spine, orthopedics, general surgery, dental, ophthalmology, urology and others.

We are currently seeking a self-motivated, charismatic individual to join our regulatory affairs team. A successful candidate for this position possesses exceptional technical skills and understanding related to working in the highly regulated medical device industry. This individual will have direct support from leadership and team members through training and continuous learning. We offer a very competitive salary, commensurate with the role and your experience as well as an attractive, comprehensive benefits package. If you're looking for an autonomous career opportunity while working in a transparent and positive culture that promotes professional growth and teamwork, we'd love to hear from you!

Essential Responsibilities:

Assist with regulatory pathways and strategies, premarket FDA, and international regulatory submissions
Support post-market surveillance activities and regulatory requirements
Serve as a company representative during external audits by Regulatory and Third Party Auditors
Design Control documentation assistance
Validation and Testing Protocol Development
Perform gap assessments against new and revised regulations


Bachelor's Degree in Engineering, Science, or health-related field
5-7 years' related work experience in the medical device or regulated industry
Working knowledge of FDA and other regulatory authorities
Experience with ISO 13485, FDA, MDR (Medical Device Regulation), and CMDR (Canadian Medical Devices Regulations) compliance requirements and training
Experience with Risk Management per ISO 14971
Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls
FDA regulatory submission experience (Pre-Submission, 510ks, De Novo, IDEs)
International submission experience a plus
Candidate must be a self-starter, self-motivated, and results oriented
Excellent interpersonal and written communication skills
Must be able to work independently and have ability to work with cross-functional teams
Extensive project management skills with the ability to work under tight timelines and able to multi-task

This position involves all aspects of Regulatory Affairs, including customer consultation, marketing support, design and development support, and post launch surveillance for our customers.

Benefits of Employment:
Competitive Base Salary plus Bonus potential
Benefits: Medical, Dental, Vision, Life Insurance, 401(k) match, generous PTO and 12 Paid Holidays, Wellness Program with Fitness Center and Training Classes, Flexible Schedule including remote work from home days
Company cell phone and laptop
Training and support in developing your understanding of medical device development, regulatory affairs, and quality management systems
Exciting, fast-paced, and team-oriented culture with fun company outings and team building activities
Great opportunity to get in on a growing, enthusiastic company and establish yourself as a long-term key member

Keywords: JALEX Medical, LLC, Cleveland , Regulatory Affairs Specialist, Other , Cleveland, Ohio

Click here to apply!

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