Regulatory Affairs Specialist

Prentke Romich GmbH

. Manage regulatory submissions, registrations, renewals, and related documentation for domestic and international markets.

Posted 9/24/2026full-timeWooster • Ohio • United StatesMid-LevelSenior💰 $60,000 - $75,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Expertise in regulatory submissions, compliance assessments, and technical documentation management in the medical device, pharmaceutical, or biotechnology sectors. Strong analytical and communication skills to effectively guide product development and navigate regulatory landscapes.

Highest-signal resume keywords

Regulatory Affairs ExperienceRegulatory ComplianceTechnical Documentation ManagementRegulatory Research and AnalysisCollaboration with Stakeholders

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory SubmissionsRegulatory GuidanceProduct RegistrationsRegulatory AuditsRisk AssessmentsRegulatory Changes MonitoringQuality System StandardsRegulatory Compliance AssessmentsLabeling ReviewMarket Expansion Activities

Soft Skills

Excellent Communication SkillsAnalytical ThinkingProblem-Solving AbilitiesOrganizational SkillsAdaptability

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

Medical DevicesPharmaceuticalsBiotechnologyRegulated EnvironmentDeclarations of Conformity

About the role

Key responsibilities & impact

Manage regulatory submissions, registrations, renewals, and related documentation for 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 for regulatory compliance.
Monitor regulatory changes, assess business impact, and recommend process improvements.
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.

Requirements

What you’ll need

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.
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.

Benefits

Comp & perks

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 expertise in medical device regulations, software as a medical device (SaMD), and global compliance requirements.