Regulatory Affairs Specialist

Overview

This role supports a partner organization in the United States that handles applications and hiring steps directly. It is centered on regulatory work for innovative medical device products in a tightly controlled healthcare environment.

The position involves guiding regulatory strategy, preparing filings, and helping ensure products stay compliant with applicable global requirements throughout their lifecycle. You will work across functions to turn complex regulatory rules into practical actions that support business goals and patient needs.

It is a hands-on, strategic role that combines technical review, compliance expertise, and problem-solving to help products reach and remain on the market. You will also act as a knowledgeable resource for project teams and partner closely with engineering, quality, and product stakeholders.

Key responsibilities

• Drive regulatory work needed to secure and sustain global approvals for medical devices.
• Build regulatory plans for new products, geographic expansion, launches, and post-market updates.
• Assess submission needs and filing requirements for the markets assigned to you.
• Explain regulatory expectations to internal teams and outside partners in a clear, practical way.
• Examine technical files and supporting evidence to confirm they meet regulatory standards.
• Coordinate with technical, quality, engineering, and business teams to prepare and maintain submissions.
• Analyze regulatory data, draft summary materials, and help answer questions from authorities or reviewers.
• Contribute to labeling, claims, and related documentation so that they remain compliant.
• Act as a subject matter resource for project teams during product development and commercialization.
• Spot regulatory issues and work through them using applicable standards, guidelines, and requirements.

Requirements

• A bachelor’s degree in life sciences, engineering, medical technology, regulatory science, or a closely related discipline.
• At least 2 years of experience in medical device regulatory affairs or quality assurance.
• Working knowledge of current regulatory frameworks and how to apply them in practice.
• Familiarity with FDA regulations, guidance documents, and medical device compliance expectations.
• Ability to interpret technical information and judge whether it aligns with relevant laws, standards, and rules.
• Experience reviewing regulatory documentation and supporting product submission efforts.
• Strong analytical and problem-solving skills, with the ability to manage multiple priorities and deadlines.
• Excellent written and spoken communication skills for cross-functional collaboration.
• Comfort working independently while also contributing effectively in a team setting.
• Willingness to travel occasionally, up to about 5%.

Benefits

• Competitive annual pay in the range of USD 79,000 to USD 119,000, depending on location, experience, education, skills, and qualifications.
• Eligibility for bonus and/or incentive compensation.
• Medical, dental, and vision insurance coverage.
• Life insurance and disability coverage.
• 401(k) retirement contribution options.
• Paid time off and wellness resources for employees.
• Access to employee assistance programs and employee resource groups.
• Opportunities for continued education, training, and professional development.
• Growth potential within a global healthcare-focused organization.
• An inclusive culture that emphasizes belonging, collaboration, and employee development.

Application and privacy information

The hiring partner oversees the application process and the next stages. A shortlist of top-matching candidates is created using an AI-assisted matching process, after which the employer manages interviews, assessments, and final decisions.

By submitting an application, candidates agree that the recruiting platform may process personal data to assess candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws, including GDPR. Applicants may exercise rights such as access, correction, deletion, and objection at any time.

The recruitment process may also use AI tools to help review applications, analyze resumes, assess responses, and identify possible inconsistencies or verification signals. These tools support the hiring team but do not replace human judgment, and final hiring decisions are made by people. Applicants may contact the company for more information about data processing.