Regulatory Affairs Associate

Essential responsibilities include but are not limited to:

General

• Adhere to all company policies, procedures and comply with all safety & regulatory requirements;
• Monitor and measure metrics and present relevant data to the management;
• Ability to recognize issues and develop solutions for continuous improvement.

Regulatory Affairs Associate/Specialist

• Coordinate efforts associated with the preparation of regulatory documents or submissions;
• Coordinate, prepare, or review regulatory submissions for domestic or international projects;
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance;
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures;
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents;
• Recommend changes to company procedures in response to changes in regulations or standards;
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies;
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review;
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues;
• Compile and maintain regulatory documentation databases or systems;
• Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes;
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies;
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation;
• Review study protocols to ensure appropriate collection of data needed for regulatory submissions;
• Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.

Basic Qualifications:

• Authorization to work in the US for any employer without requiring further sponsorship.
• A minimum of Bachelor’s in Regulatory Science, Life Sciences, Medical Technology.
• Minimum of 2 experience in a regulated medical device environment.

Preferred Qualifications:

• Keen attention to details; ability to write clear and concise text for regulatory submissions SOPs and other technical documentation;
• Timeline/Deadline driven work ethic;
• Demonstrated ability to work efficiently independently; as well as in a team-based environment to organize & manage projects with multiple priorities; and assigned tasks;
• Effective team player and ability to collaborate with cross functional teams;
• Proactive, planning and exhibits high level of critical thinking abilities;
• Strong verbal and written communication skills;
• Enthusiastic demeanor with a can-do attitude;
• Proficiency in MS office (Word, Excel, PowerPoint and other applications

Women and Minorities are encouraged to apply.