This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Specialist based in United States.
This role offers the opportunity to support the development, approval, and maintenance of innovative medical device products in a highly regulated healthcare environment.
You will help shape regulatory strategies, prepare submissions, and ensure products meet global compliance requirements throughout their lifecycle.
Working closely with cross-functional teams, you will translate complex regulations into actionable pathways that support business and patient needs.
The position combines regulatory expertise, technical evaluation, and strategic problem-solving to advance product approvals and market access.
You will contribute as a subject matter resource while collaborating with engineering, quality, and product teams.
This is an impactful opportunity for a detail-oriented regulatory professional looking to grow within a global medical technology organization.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs Specialist based in United States.
This role offers the opportunity to support the development, approval, and maintenance of innovative medical device products in a highly regulated healthcare environment.
You will help shape regulatory strategies, prepare submissions, and ensure products meet global compliance requirements throughout their lifecycle.
Working closely with cross-functional teams, you will translate complex regulations into actionable pathways that support business and patient needs.
The position combines regulatory expertise, technical evaluation, and strategic problem-solving to advance product approvals and market access.
You will contribute as a subject matter resource while collaborating with engineering, quality, and product teams.
This is an impactful opportunity for a detail-oriented regulatory professional looking to grow within a global medical technology organization.
Accountabilities:
- Plan and execute regulatory activities required to obtain and maintain global approvals for medical devices.
- Develop regulatory strategies for new products, market expansions, product launches, and post-market changes.
- Determine regulatory requirements for product submissions and filings across assigned markets.
- Communicate regulatory expectations and requirements to internal stakeholders and external partners.
- Review technical documentation and supporting evidence to ensure alignment with regulatory standards.
- Prepare and maintain regulatory submissions by collaborating with technical, quality, engineering, and business teams.
- Evaluate regulatory information, draft summary documentation, and support responses to regulatory questions or requests.
- Provide input on product labeling, claims, and supporting documentation to ensure compliance.
- Serve as a regulatory resource and subject matter contributor for project teams.
- Identify and resolve regulatory challenges by applying knowledge of applicable standards and guidelines.
- Bachelor’s degree in life sciences, engineering, medical technology, regulatory science, or a related field.
- Minimum of 2 years of experience in medical device regulatory affairs or quality assurance.
- Understanding of current regulatory environments and the ability to apply regulatory requirements effectively.
- Knowledge of FDA regulations, guidelines, and medical device compliance expectations.
- Ability to analyze technical information and determine alignment with applicable standards, laws, and regulations.
- Experience reviewing regulatory documentation and supporting product submissions.
- Strong problem-solving skills with the ability to manage multiple priorities and meet deadlines.
- Excellent written and verbal communication skills for collaboration with cross-functional teams.
- Ability to work independently while contributing effectively within a team environment.
- Willingness to travel occasionally, up to approximately 5%.
- Competitive annual salary range of $79,000 - $119,000 USD, depending on location, experience, education, skills, and qualifications.
- Bonus and/or incentive compensation eligibility.
- Comprehensive healthcare benefits, including medical, dental, and vision coverage.
- Life insurance and disability benefits.
- 401(k) retirement contribution options.
- Paid time off and employee wellness resources.
- Access to employee assistance programs and employee resource groups.
- Opportunities for continuing education, training, and professional development.
- Career growth opportunities within a global healthcare-focused organization.
- Inclusive workplace culture focused on belonging, collaboration, and employee development.
The Regulatory Affairs Specialist will support global regulatory activities by developing submission strategies, maintaining regulatory filings, and ensuring compliance with applicable medical device requirements. This role requires strong attention to detail, effective collaboration, and the ability to interpret regulatory standards to support successful product commercialization.
Requirements:
The ideal candidate is a regulatory professional with experience supporting medical device approvals and quality compliance activities. They should have strong analytical abilities, knowledge of regulatory frameworks, and the communication skills needed to collaborate across technical and business teams.