Regulatory Affairs Manager

Primary Function of Position:

As a Regulatory Affairs Manager/Director-your primary function will be to prepare regulatory FDA submissions for CapsoVision’s products including pre-submissions. You will work closely with cross-functional teams to ensure timely execution of projects/response to inquiries. Additionally, you will provide support to the Sr. Regulatory Affairs Director in addressing internal and external information requests related to premarket/post market activities.

Roles and Responsibilities:

Main activities

• Coordinate and facilitate communication and information flow for premarket regulatory activities.
• Prepare response to the inquires for FDA requirements
• Engage with cross-functional teams, including R&D, Quality Assurance, and Clinical Affairs, to gather and integrate relevant data for regulatory submissions.
• Support the implementation of risk control measures and strategies for product development and post-market surveillance.
• Collaborate with stakeholders to identify potential risks, assess their impact, and develop mitigation strategies.
• Ensure regulatory compliance by maintaining knowledge of applicable regulations and standards.
• Assist in the preparation and submission of regulatory documentation and reports.
• Utilize project management skills to plan, execute, and monitor regulatory projects.
• Provide assistance to the Sr. Regulatory Affairs Director in addressing internal and external information requests for premarket or post market activities.
• Actively engage in process improvement initiatives to streamline and optimize the regulatory process and procedures.
• Work closely with cross-functional teams to identify and escalate any deficiencies to the relevant subject matter experts (SMEs).
• Support reviews and approvals of materials intended for regulatory submissions, ensuring compliance with regulations and guidelines.

Additional activities

• Supports Quality Management system activities, such as CAPA, Customer Complaints and Internal Audits
• Participates in internal/external audits and inspections, and ensures that company procedures, processes and documentation meet the requirements of the Quality Management System, ISO 13485 and other applicable regulations.
• Supports process improvement and implementation of regulatory projects and tools.
• Assists and supports other employees, teams and field personnel as necessary.
• Assists with product recalls and field corrections
• Other regulatory tasks and projects may be assigned as necessary.

Qualifications

Required Knowledge, Skills, and Experience:

Knowledge:

• Have comprehensive knowledge of normative and regulatory requirements for medical devices, such as ISO 13485:2016, ISO 14971:2019 and 21CFR820.
• Proven project management experience, including planning, execution, and monitoring of projects.
• Strong knowledge of regulatory requirements and risk management principles
• Proficiency in regulatory affairs software and systems.
• Proven record for successful FDA 510(k) submissions
• General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook).

Experience:

Minimum of 5 years of experience in regulatory affairs and 8 years of overall industry experience. A Bachelor’s or master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function).

Interpersonal skills

• Demonstrate organizational and planning skills, including action oriented, focus urgency and driving for results, ability to manage multiple tasks simultaneously
• Proactive problem-solving skills and ability to work independently and in a team environment.
• Familiarity with process improvement methodologies and a continuous improvement mindset.
• Demonstrate good interpersonal skills, ability to work with cross department environment.
• Excellent communication and interpersonal skills, with the ability to interact effectively with diverse stakeholders.
• Detail-oriented mindset, ensuring accuracy and attention to regulatory details.
• Orientation for work result details, with emphasis on accuracy and completeness
• Fluent in written and spoken English.
• Strong attention to detail and ability to analyze complex information and regulatory requirements.

Preferred Knowledge, Skills, and Experience:

• US FDA 21 CFR 807 knowledge is a must
• US FDA 21 CFR 803/806/820 basic knowledge would be a plus

Additional Information:

CapsoVision Inc., is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

The salary depends on the experience and it is negotiable.

Job Type: Full-time

Pay: $150,000.00 - $300,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• Have you lead 510(k) submission?

Experience:

• FDA questions/interactive review: 2 years (Required)

Work Location: In person