Regulatory Affairs Specialist

PRC-Saltillo; Wooster (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

PRC-Saltillo seeks a Regulatory Affairs Specialist to ensure medical devices and SaMD meet regulatory requirements across the US, Canada, Europe, and other markets.

You will manage submissions, provide regulatory guidance, and maintain extensive technical documentation while collaborating with engineering, quality, and product teams to enable safe, compliant solutions.

Qualifications

• Bachelor’s degree in life sciences, engineering, business, or related field required.
• Minimum five years of regulatory affairs experience in medical devices, pharma, or biotech.
• Proficiency with MS Word, Excel, and PowerPoint.

Responsibilities

• Manage regulatory submissions, registrations, renewals, and related documentation for domestic and international markets.
• Provide regulatory guidance for product development, manufacturing, labeling, and market expansion.
• Create and maintain technical documentation, declarations of conformity, and regulatory files.
• Review changes in labeling and marketing materials for regulatory compliance.
• Monitor regulatory changes and advise on process improvements to stay compliant.
• Represent regulatory affairs on cross-functional project teams and audits.

Skills

Regulatory research

Regulatory analysis

Regulatory communications

Audits & compliance

Cross-functional collaboration

Prioritization & multitasking

Education

Bachelor’s degree in Life Sciences/Engineering/Business

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Help Bring Innovative Communication Solutions to Market – Join PRC-Saltillo as a Regulatory Affairs Specialist!

At PRC-Saltillo, our mission is to empower individuals through innovative communication solutions. As a Regulatory Affairs Specialist, you’ll play a key role in ensuring our medical devices and software products meet regulatory requirements across the United States, Canada, Europe, and other global markets. You’ll collaborate with cross-functional teams, provide regulatory guidance, manage product registrations, and help bring life-changing technology to the people who depend on it.

If you're passionate about regulatory compliance, enjoy solving complex challenges, and want to make a meaningful impact in a mission-driven organization, we’d love to hear from you!

Why You’ll Love Working Here

• Meaningful Impact: Help ensure innovative communication technologies reach the individuals who rely on them.
• Global Reach: Support regulatory activities across multiple international markets and regulatory bodies.
• Collaborative Environment: Work closely with engineering, quality, product development, and business teams.
• Professional Growth: Expand your expertise in medical device regulations, software as a medical device (SaMD), and global compliance requirements.

Duties and Responsibilities:

• Manage regulatory submissions, registrations, renewals, and related documentation to support compliance in domestic and international markets.
• Provide regulatory guidance for product development, manufacturing, labeling, marketing, distribution, and market expansion activities.
• Create, maintain, and support technical documentation, product registrations, Declarations of Conformity, and regulatory files.
• Review product changes, labeling, marketing materials, and documentation to ensure compliance with applicable regulations.
• Monitor regulatory changes, assess business impact, and recommend process improvements to maintain compliance.
• Represent Regulatory Affairs on project teams and provide regulatory expertise across the organization.
• Support risk assessments, product recalls, medical device reporting activities, and regulatory audits as needed.

Education and Experience:

• Bachelor’s Degree in Life Sciences, Engineering, Business, or a related technical field is required.
• A minimum of five (5) years of regulatory affairs experience in a regulated environment such as medical devices, pharmaceuticals, or biotechnology is required.
• Knowledge of Microsoft Word, Excel, and PowerPoint is required.

Required Skills and Abilities:

• Ability to conduct detailed regulatory research, analysis, and compliance assessments.
• Strong understanding of regulatory requirements and quality system standards.
• Excellent written and verbal communication skills with the ability to explain complex regulatory concepts to diverse audiences.
• Strong analytical, critical thinking, and problem-solving abilities.
• Ability to lead or participate in regulatory and compliance audits.
• Demonstrated ability to collaborate effectively with internal and external stakeholders.
• Self-motivated, adaptable, and able to manage multiple priorities in a changing environment.
• Strong organizational skills and attention to detail.