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.
