Regulatory Affairs Associate

Job Title:

Regulatory Affairs Specialist

Job Description

The Regulatory Affairs Specialist plays a key role within the Quality and Regulatory department by implementing and overseeing the regulatory system to strengthen compliance and improve operational efficiency for medical device products, with a focus on Class II devices. This position prepares and manages regulatory submissions for new and existing products, interprets and applies regulatory requirements, and partners closely with internal teams and regulatory agencies to ensure products meet all applicable domestic and international standards.

Responsibilities

+ Prepare complete and accurate regulatory documents and submissions for new products under development and for changes to existing products.

+ Communicate proactively with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, required compliance testing, and clarification or follow-up for submissions under review.

+ Coordinate, prepare, and review regulatory submissions for both domestic and international projects, ensuring timely and compliant delivery.

+ Interpret regulatory rules, guidance documents, and rule changes, and translate them into clear internal policies, procedures, and work instructions.

+ Provide technical review of data, reports, and supporting documentation to be included in regulatory submissions, ensuring scientific rigor, accuracy, and clarity.

+ Review product promotional materials, labeling, batch records, specification sheets, and test methods to verify compliance with applicable regulations, standards, and internal policies.

+ Advise cross-functional project teams on premarket regulatory requirements, export and labeling requirements, and clinical study compliance issues.

+ Determine the appropriate types of regulatory submissions or internal documentation required for proposed device modifications or labeling changes.

+ Identify relevant guidance documents, international standards, and consensus standards, and provide interpretive assistance to internal stakeholders.

+ Prepare or coordinate the preparation of additional information and responses requested by regulatory agencies during the review process.

+ Prepare, organize, and maintain technical files and regulatory documentation necessary to obtain and sustain product approvals and certifications.

+ Conduct and support internal audits related to regulatory and quality system requirements, and contribute to corrective and preventive actions.

+ Evaluate systems and processes, identify performance indicators, and recommend actions to improve or correct performance relative to regulatory and quality goals.

+ Define problems, collect data, establish facts, and draw valid conclusions to support regulatory decision-making and problem resolution.

+ Apply logical and scientific thinking to interpret complex technical instructions and manage multiple abstract and concrete variables.

+ Collaborate effectively in a team environment, contributing to a positive culture and strong cross-functional relationships.

+ Use basic office equipment and software to create, manage, and store regulatory documentation and correspondence.

+ Perform additional duties as assigned by supervisory or management personnel in support of quality and regulatory objectives.

Essential Skills

+ Bachelors degree in a scientific discipline or a related field.

+ At least 2 years of previous work experience in a similar regulatory position, preferably within the medical device industry.

+ Solid knowledge of regulatory requirements for Class II medical devices.

+ Strong understanding of FDA Quality System Regulations (cGMP) and related international standards for medical devices, including 21 CFR Part 820.

+ Knowledge of ISO 13485 and ISO 14971 standards and their application to medical device quality and risk management systems.

+ Familiarity with basic laboratory equipment and analytical instrumentation relevant to medical device development and testing.

+ Proficiency in Microsoft Word, Excel, and Outlook for preparing documents, reports, and correspondence.

+ Ability to use web browsers such as Internet Explorer, Chrome, or Firefox to research regulatory information and access online systems.

+ Effective verbal and written communication skills, with the ability to convey complex regulatory information clearly to diverse audiences.

+ Strong active listening skills, with the ability to fully understand stakeholder needs, ask clarifying questions, and respond…