Regulatory Affairs Specialist II

What You'll Work On

• Under direct supervision, prepare moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), CE-Mark Technical Dossier, UKCA Mark, other regional Regulatory submissions, non-US Clinical Trial Submission, Shonin, and Certificates to Foreign Government
• Track multiple projects concurrently
• Ensure that existing approvals and documentation are maintained
• Communicate with in-country RA personnel to facilitate global clearance/approvals
• Monitor, research, and obtain information on FDA clearances/approvals of competitors, and proactively share this information with interested parties
• Communicate with regulatory agencies under direct supervision
• Perform reviews with some oversight of design control documents (e.g., engineering protocols, reports, product drawings, etc.), quality system procedures relating to commercialization, labeling (e.g., Instructions for Use, product labels, promotional materials), and risk management to ensure regulatory compliance.
• Assist in performing moderately complex research to support strategic planning
• Analyze existing systems and procedures, recommend solutions/improvements, and write or revise Work Instructions and SOPs as needed to support departmental functions and the Quality System
• Understand the Quality System, biocompatibility requirements, Design Control, Medical Device Directive, Essential Requirements, ISO 13485, labeling requirements, Quality System Regulation, Canadian regulations, export requirements, and regulatory requirements of pertinent regions
• Assist in activities (e.g., execution, documentation) related to Field Corrective Actions.

What You Contribute

• A Bachelor's degree in science discipline or related field with 2+ years of experience, or equivalent combination of education and experience
• Regulatory Medical Device experience preferred
• Proven ability to use and apply technical standards, principles, theories, concepts, and techniques.
• Strong oral, written, and interpersonal communication skills
• High degree of accuracy and attention to detail
• Proficiency with MS Word, Excel, and PowerPoint
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

Working Conditions

General office and laboratory environment. Willingness and ability to work on site. May have business travel from 10% - 30%. Potential exposure to blood-borne pathogens. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed. Must be able to communicate and exchange accurate information with employees at all levels daily.