Regulatory Affairs Specialist I

Alameda, CAfull timeOn Site

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entry

$77k–$98k

H1B: no

Penumbrainc Regulatory Affairs Specialist I at Penumbrainc responsible for preparing and maintaining document packages for worldwide regulatory submissions. Supports global clearance and compliance activities.

Responsibilities

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

Qualification

Excellent writtenProficiency in WordRegulatory Medical Device experience

Required

Bachelor’s degree in a relevant discipline 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
Excellent written, oral, and interpersonal communication skills
Proficiency in Word, Excel, PowerPoint and other computer tools

Preferred

Regulatory Medical Device experience

Benefits

Equity/RSU

Company

Penumbrainc

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Source: lever

Active within the past hour

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Regulatory Affairs Specialist I at Penumbrainc · LumiJobs