The Staff Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to product design teams, change control, and regulatory product submissions.
Essential Duties and Responsibilities
- Collaborates as a core team member on new product development teams. Independently determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities.
- Prepares regulatory submissions including 510(k) premarket notifications for US FDA.
- Prepares regulatory submissions including technical files/design dossiers for registration of products in European Union and interfaces as needed with Notified Bodies regarding significant changes to products.
- Responsible for internal process improvements, data/metric evaluation, maintenance of databases, and public-facing information.
- Assists with post market surveillance evaluation, trending, and reporting including updates to risk management (e.g., FMEA) process.
- Reviews product labeling and promotional materials to ensure consistency with regulatory approvals.
- Researches sources of regulatory information (e.g., regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc.).
- Provides department support during internal and external audits.
- Assists in developing, maintaining, assigning, and tracking company Standard Operating Procedures (SOPs) to ensure compliance with applicable global regulatory requirements.
- Maintains FDA establishment listings and registration.
- Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, MDD 93/42/EEC, MDR 2017/745, 21 CFR 820, global medical device registration, technical writing, and external standards.
- Other duties as assigned
- Typically requires a bachelor's degree and five years of experience in the medical device industry.
- Strong knowledge of FDA Quality System Requirements (QSR), ISO 13485, MDD 93/42/EEC, and MDR 2017/745.
- Orthopaedic or spine experience preferred.
- RAC certification preferred.
- Must have 510(k) submission experience.
- Must be detail oriented and possess strong technical writing skills.
- Must possess strong interpersonal communication, teamwork and organizational skills.