Regulatory Affairs Specialists III

Job Description

Duties and Responsibilities:

• Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets.
• Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc.), product claims and country regulatory dependencies to ensure optimized sequencing for submissions.
• Works with a cross functional team to prepare and submit regulatory submissions such as 510(k)s, MDR EU Technical Files, or submissions to other global regulators such as NMPA, TGA, etc., for the purpose of obtaining authorization for market launch.
• Assesses changes in existing products to and determines the need for new / revised licenses or registrations.
• Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
• Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
• Contributes to writing and editing technical documents.
• Researches, analyzes, integrates, and organizes background information from diverse sources for regulatory submissions.
• Ensures compliance with pre- and post-market product approval requirements.
• Supports regulatory inspections, as required.

Qualifications:

• Bachelor’s degree from an accredited university or college, preferred in a Scientific, Engineering, Regulatory, Legal, or core Life Science discipline.
• 4+ years’ experience in a highly regulated industry, preferred in Regulatory Affairs, or equivalent experience through advanced degree or other relevant education and experience.
• Strong verbal and written communication, and presentation skills, with the ability to speak and write clearly and convincingly in English.
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and collaboration applications.

Desired Characteristics:

• Demonstrated ability to analyze and resolve problems.
• Ability to document, plan, market, and execute programs.
• Established project management skills.
• A team player and collaborator.
• Preferably, Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).
• Experience in medical device regulatory affairs.
• Demonstrated life-long learner; eagerness to obtain new skills and knowledge.