The Regulatory Affairs Specialist will be responsible for activities related to execution of established regulatory strategy leading to successful registration and life-cycle management of unique products serving patients with unmet medical needs. As an integral member of the Regulatory Affairs team, this position is versatile and executes various activities with both RA compliance and RA submission responsibilities.

This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory compliance and submission processes. This individual will provide a sense of urgency to cross-functional teams assisting with global programs and ensure effective communication with business partners worldwide.

Essential Job Functions

• Review labeling, training, and promotional material
• Support product and shipping release.
• Maintenance of FDA's GUDID database
• Technical file update and reviews
• Review of External Standards
• Support business with government queries and registration documentation requirements.
• Review Change Orders and assess regulatory impact of product changes on US and/or International regulatory strategy and submissions
• Support post market regulatory compliance activities for US/International product approvals
• Assist with the development and maintenance of regulatory affairs department procedures
• Comply with applicable FDA and international regulatory laws/standards
• Ensure relevant ISO and FDA Export requirements are met, as required
• Performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Compiles all materials to support submissions, license renewal and annual registrations.
• Keeps abreast of regulatory procedures and changes.
• Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
• Customer Service Support
• Proactively drive activities to meet and/or exceed company objectives.
• Maintain regulatory files/database and chronologies in good order.
• Manage interactions with distributors, consultants, and/or partners.
• Perform other related duties and responsibilities as assigned.

Requirements

Qualifications

• Bachelor's Degree required
• At least 3 years of increasing Regulatory Affairs (Medical device and/or Pharma) experience
• Solid working knowledge of relevant domestic and global regulations and guidance
• Exercise outstanding judgment in all areas of responsibility.
• History of successful interactions with global regulatory authorities
• Computer proficient to include web browser/internet search, MS Outlook, Word, Excel, and Power Point capabilities. Technical competence includes the ability to learn new software and systems.
• A combination of education and experience may be considered

Competencies

• Ability to perform at high levels in a thriving environment, preferably in the medical device industry or combination products industry.
• Knowledge of FDA, MDD, EU MDR
• Knowledge of Pharma is a plus
• and ISO regulations/standards, including ISO 10993 (requirements for biocompatibility).
• RAC certification is a plus.
• Ability to focus and achieve scheduled milestones, including contingency planning.
• Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
• Strong team-working and organizational skills with a drive to complete tasks in the face of obstacles and time constraints, and a willingness to collaborate wherever needed.

Physical Requirements

Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping and reaching. Vision requirements include the ability for close vision, to adjust focus, to color code.

Mental Requirements

This position requires the ability to maintain an appropriate work pace; to comprehend and follow instructions; to read, count and compute; to exercise logic and reasoning; to organize and prioritize; to problem solve; to make decisions; to analyze and interpret data; to multi-task/re-direct and experience numerous interruptions.

Other Requirements

Some travel, approximately 15%

Work Environment

The noise level in the work environment is usually quiet to moderate.