Regulatory Affairs Specialist AngioScore
THIS JOB HAS EXPIRED AngioScore:
AngioScore?s Scoring Balloon Catheter significantly alters the landscape for treating both peripheral arterial disease and coronary artery disease.
Location and Reporting Relationship:
AngioScore is based in Fremont, California. The position reports to Sr. Manager, Regulatory Affairs
Sr. Manager, Regulatory Affairs
Implement day to day regulatory activities to ensure continual regulatory compliance with FDA, Notified Body, Health Canada and PMDA requirements. Prepare domestic and international submissions and product registration applications to obtain regulatory approval or clearance.
MAJOR DUTIES AND RESPONSIBILITIES:
Represent Regulatory Affairs as back up to Regulatory Manager on cross functional product development teams as needed.
Assist in preparation and submission of domestic paper based and electronic regulatory submissions including PMA Supplement, 510(K) premarket notification, 510(K) Notes-to-File and IDE as needed.
Prepare and submit international paper based and electronic regulatory submissions including License Applications, Seihin Hyojun Sho and Design/Technical Dossiers including associated Essential Requirements checklists and Declarations of Conformity. Also responsible for compiling/preparing response to questions concerning such regulatory submissions.
Proactively prepare and submit annual reports to FDA (in support of a PMA or IDE) and Health Canada (Obligation to Inform).
Maintain updates to the Design/Technical Dossiers for the Notified Body and Authorized Representative.
Maintain updates to Seihin Hyojun Sho for PMDA and Medical Device Licence for Health Canada.
Review and interpret technical and scientific data to ensure regulatory requirements are met; evaluate product/design and process changes for potential effect upon product safety and effectiveness; document rationales that do not require formal notification to regulatory agencies.
Maintain Notified Body and Japanese Marketing Authorization Holder communications regarding product or process changes in advance of change notifications to affect timely approval for business objectives.
Prepare and submit international regulatory registrations per national requirements. Collaborate with regulatory representative(s) of international distributors to ensure continued compliance with national regulations.
Maintain the Distributors and Approved Country List of OUS countries where AngioScore products are approved to market; ensure national requirements are met prior to distribution.
Maintain and update the External Standards Library including monitoring and communicating to AngioScore employees changes in domestic and international regulations, issuance of new guidelines, regulations and industry standards that impact the business.
Maintain regulatory submissions and correspondence files.
Plan, schedule and complete projects in a manner consistent with company and department objectives.
Prepare and maintain ?Audit Ready? documentation including but not limited to copies of logs and records supporting QSR compliance activities.
Participate in specials assignments as requested.
Bachelors of Science degree in Life Sciences, Engineering or equivalent, or minimum five years direct regulatory experience with Class II and III therapeutic devices.
Minimum five years direct regulatory affairs experience in the therapeutic medical device industry, with Bachelors of Science degree.
Knowledge of FDA regulations, including FDA Quality System Regulation (QSR), EU Council Directive 93/42/EEC (MDD), and Health Canada Medical Device Regulations SOR/98-282. Knowledgeable of Japanese Ministerial Ordinance No. 169.
Individual must be proficient with Microsoft Office software.
Language and Verbal Skills:
Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally; must have clear, confident oral presentation skills.
Analytical and Reading Skills:
Individual must have excellent analytical skills, and the ability to read, analyze, interpret and assist in the creation and refinement of regulatory submissions.
||Fremont, CA |
THIS JOB HAS EXPIRED