Senior Regulatory Affairs Specialist

Key Responsibilities:

Prepares complex submissions to gain global approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), PMA, Shonin, Design Dossier, Technical File, and Certificates to Foreign Government.

Develops and maintains positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.

Acts as a core member on manufacturing and development teams, providing feedback and guidance throughout the product development cycle. Develops and implements global regulatory strategy.

Provides input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, biocompatibility, and clinical studies.
Evaluates and approves device labeling and advertising materials for compliance with global submissions and applicable regulations; analyzes and recommends appropriate changes.

Evaluates and approves proposed changes to products and processes; develops, approves, and implements global regulatory action plans based on the changes.

Assists with departmental policy and procedure implementation.

Assists with Regulatory Affairs training to cross functional groups.

Qualifications:

Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline.
Professional certification(s) preferred.
5 -8 years Regulatory Affairs submission experience in the medical device industry. Experience with medical device systems (software driven electro-medical devices)

Thorough understanding of FDA and international regulations.
Strong working knowledge of medical devices, procedures, and terminology.
Working knowledge of clinical trial strategy and study design, statistical methods and data reporting preferred.
Working knowledge of product development process and design control.
Effective research and analytical skills.
Proficiency with Microsoft Office.
Ability to manage multiple projects.
Excellent written and oral communication, technical writing, and editing skills.
Ability to work independently with minimal supervision.