Regulatory Affairs Specialist
New
Based in United StatesFull-TimeMiddle
Salary$79,000 - $119,000 USD
Apply NowOpens the employer's application page
Job Details
- Experience
- Minimum of 2 years
- Required Skills
- ComplianceQuality Assurance
Requirements
- 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 ability to apply requirements effectively.
- Knowledge of FDA regulations, guidelines, and medical device compliance expectations.
- Ability to analyze technical information and determine alignment with 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.
- Ability to work independently and contribute to a team environment.
- Willingness to travel occasionally, up to approximately 5%.
Responsibilities
- Plan and execute regulatory activities to obtain and maintain global medical device approvals.
- Develop regulatory strategies for new products, market expansions, and post-market changes.
- Determine regulatory requirements for submissions and filings across assigned markets.
- Communicate regulatory expectations and requirements to internal and external stakeholders.
- Review technical documentation to ensure alignment with regulatory standards.
- Prepare and maintain regulatory submissions in collaboration with cross-functional teams.
- Evaluate regulatory information and draft summary documentation.
- Provide input on product labeling and claims to ensure compliance.
- Serve as a regulatory subject matter contributor for project teams.
- Identify and resolve regulatory challenges by applying standards and guidelines.
View Full Description & ApplyYou'll be redirected to the employer's site
