Engineer IT Compliance responsible for compliance activities in regulated IT systems. Building partnerships with IT functions and ensuring regulatory alignment in pharmaceutical industry.
About the role
- Regulatory Affairs Specialist providing regulatory support for medical device life cycle and compliance. Collaborating with teams, preparing submissions, and ensuring regulatory compliance for products.
Responsibilities
- Provide regulatory support through the product life cycle
- Prepare and audit 510(k)s, IDEs, PMA and/or international submissions
- Collaborate with FDA and international reviewers
- Review and approve product labeling and marketing claims
- Support required for CE marking activities
Requirements
- BS in a scientific field
- 1+ years employment in medical device product registration, compliance or quality systems
- Regulatory Affairs Certification (RAC) desired
- Knowledge of U.S. and European medical device regulations preferred
- Excellent written and verbal communication skills
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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