Regulatory Affairs Specialist (Brecksville, OH)

Cedent Consulting Inc.; Brecksville (OH); On-site; USD 70,000 - 100,000; Full time

Job summary

A leading company in regulatory affairs seeks a Regulatory Affairs Specialist to join their team in Brecksville, OH. The role involves preparing regulatory submissions, maintaining compliance with standards like FDA and ISO, and supporting various projects. Candidates should possess a degree and relevant experience in regulated industries, along with strong attention to detail and communication skills.

Qualifications

• Experience in medical, legal, or regulated industries preferred.
• Knowledge of FDA regulations and ISO 13485 is preferred.
• Experience with labels and DFUs is preferred.

Responsibilities

• Prepare and submit regulatory documentation to agencies.
• Maintain compliance with FDA, ISO, and other standards.
• Collaborate on regulatory filings for international product registration.

Skills

Attention to Detail

Effective Communication

Team Collaboration

Task Prioritization

Education

Bachelor’s Degree or higher

Minimum of 2-year college degree

Tools

Microsoft Office Suite

Job description

Regulatory Affairs Specialist (Brecksville, OH)

This position is responsible for preparing submissions to various regulatory agencies. Additionally, the position will help maintain and improve upon domestic and international compliance. Candidate must possess the ability to work well in a team environment and demonstrate great attention to detail.

Duties and Responsibilities:

• Prepare and submit regulatory documentation, such as FDA 510(k) premarket notifications, to regulatory agencies including FDA, Notified Bodies, and Authorized Representatives.
• Prepare, maintain, and submit European Medical Device Directive and European Medical Device Regulation compliant Technical Files.
• Create and modify regulatory procedures to remain in compliance with FDA, ISO, European, Canadian, and other standards.
• Collaborate with the international department on regulatory filings for product registration in different countries.
• Provide regulatory support for various projects as needed.
• Update personnel on new and revised processes and procedures.
• Organize and archive internal documentation related to Engineering and Quality Systems.
• Prepare change order documentation and route for approval.

Supervisory Responsibilities:

None

Minimum Qualifications:

• Minimum of 2-year college degree; Bachelor’s Degree or higher preferred.
• Relevant work experience, ideally in the medical, legal, or other regulated industries.
• Experience creating and revising labels and DFUs is preferred.
• Knowledge of European, ISO 13485, and FDA regulations is preferred.
• Understanding of international GMP guidelines is desirable.

Skills and Abilities:

Ability to communicate effectively across functions and professional levels; proficient in Microsoft Office Suite; capable of working independently and as part of a team; able to prioritize tasks.

Physical and Mental Requirements:

Must be able to communicate effectively, analyze complex information, interpret written materials, and work collaboratively. Physical requirements include communication over long periods and computer use. Moderate noise levels and limited physical risks are expected.

Additional Requirements:

Pass a drug, alcohol, and criminal background check if required.