Sr. Regulatory Affairs Specialist

Job Summary
Responsible for handling complex submissions with minimal supervision. Organizes regulatory information and tracks and controls submissions. Reviews and advises on labeling for compliance with regulatory filings. Reviews product changes for impact on regulatory filings worldwide. Research regulatory issues and provides guidance and advice to colleagues.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

Completes submissions for countries that have complex requirements such as US FDA (510(k)s) Canada, China and/or EU with minimal supervision.
Creates Regulatory plans for cross functional teams as input into design and development
Executes Regulatory plans domestically and internationally
Work interdepartmentally to satisfy international requirements during registration.
Provide regulatory guidance to assigned product development team to ensure the documents the team develops will meet the needs of the regulatory submissions.
Timely compile materials for license renewals, updates and registrations.
Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners.
Review labeling and labels for compliance with regulatory requirements.
Review changes to existing products and SOPs to define the requirements for regulatory submissions.
Provide regulatory reviews of customer complaints and define the regulatory reportability.
Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products.
Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes.
Participate in research and resolution of regulatory issues. Disseminates regulatory information to Production, QA, QC and R&D departments and senior management as required.

Embody and live our company Values.

Qualifications

Education
☒ Bachelor’s degree required

Specific Area of Study: Engineering or a scientific field

Experience
☒ 5 to 8 years relevant experience

Specific Related Experience: Within Quality / Clinical / Regulatory discipline.

Skills

Excellent communication skills.
Ability to manage multiple priorities.
Requires creative, problem-solving ability and oral and written presentation skills.
Team oriented, the ability to work in small team environment is essential; must also be a self-starter with the ability to work independently.
Good planning and organization skills are vital.
Strong critical thinking and problem-solving skills.
Effective verbal and written communication skills are essential.
Knowledge of US and international medical device regulatory requirements.
Experience with submitting 510(k)s is mandatory.
Experience with electromechanical and/or software devices is a plus.
Strong understanding of design controls.
International experience is required.
Requires proficiency with standard software (Word, Excel, PowerPoint, etc.).
The ability to meet deadlines and be detailed orientated is necessary.

Physical Demands
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

☒ Sit; use hands to finger, handle or feel objects, tools, or controls.
☒ Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.