Regulatory Affairs Manager

Location: On-Site

At SprintRay, we are in a super-charged growth mode and are constantly looking for ways to maintain the quality of our products and processes while growing at a phenomenal pace. To help grow and maintain the regulatory and quality standards, we are seeking a Regulatory Affairs (RA) Manager to provide RA support to ensure compliance with FDA QSR, ISO 13485, and MDSAP for all SprintRay products as well as provide regulatory guidance for applicable standards and requirements.

Job Duties and Responsibilities:

• Prepare and submit product registrations and submissions (510(k), PMA) to FDA and Technical Files to other regulatory bodies (i.e.., EU notified bodies, Health Canada, Japan PMDA, etc.).
• Supports and maintains 510(k) dossiers, Technical Files, and other global regulatory submissions, certifications, and declarations of conformity in support of global product registrations.
• Maintains company registrations and device listings globally (in the US, Canada, Brazil, Japan, the EU, etc.)
• Informs coordinator of product recalls.
• Remain consistently up to date on ISO standards 21CFR 820 and CE marking processes as well as other applicable global regulations and guidelines.
• Evaluates and ensures compliance with applicable regulations, project policies, and procedures
• Reviews and writes standard operating procedures (SOPs) and other RA/QA policies as necessary.
• Review and approve claims and labeling advertising
• Determine when exemptions and exceptions can be used
• Lead process review meetings with internal departments
• Initiate process improvements and systems enhancements as identified
• Dissemination of regulatory information to product development marketing and clinical affairs organizations
• Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
• Performs and supports internal, external, and third-party audits
• Composes audit plans and reports.
• Conducts audits and inspections of GMP and non-regulated documentation.
• Tracks internal and external corrective and preventive actions.
• Performs other related duties and projects as business needs require at direction of management.

Key Qualifications:

• Bachelor’s degree in a scientific discipline or related field (Master's or Ph.D. a plus)
• 7+ years of experience in all aspects of Global Regulatory Affairs in the Medical Device Industry
• Comprehensive understanding of US and international (i.e., Canada, European Union, Japan, LATAM, etc.) medical device (software, hardware, and material) regulations/standards and quality principles
• Risk management experience (ISO 14971:2019)
• Ability to effectively interface with all levels of notified body and regulatory agency representative
• Proficient knowledge of general office procedures.
• Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook).
• Proficient quantitative and analytical skills.
• Demonstrated prioritization and time management skills.
• Demonstrated negotiation abilities.
• Demonstrated knowledge and understanding of related State and Federal regulations and procedures.
• Demonstrated high standard of quality of work.
• Demonstrated knowledge of FDA 510K and ISO 13485 Standards.
• Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections).
• Demonstrated reliability, dependability, and flexibility in work habits.
• Demonstrated attention to detail and accuracy.
• Ability to analyze and collate data for presentations and reports.
• Ability to prioritize and organize project tasks and goals effectively.
• Ability to maintain confidentiality, exhibiting high level of integrity, and trustworthiness.
• Ability to interpret and collate data to present an accurate picture of market potential.
• Ability to research new and emerging technologies and practices.
• Ability to read technical diagrams, graphs, and instructions.
• Technical writing skills
• Attention to detail

Target Salary Range: $85,000- $135,000

Actual compensation packages consider a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The estimate provided has not been adjusted for all of these factors. At SprintRay, it is not typical for an individual to be hired at or near the top of the range for their role. The total compensation package for a position may also include an annual performance bonus, medical/dental/vision benefits, and/or other applicable compensation.