Purpose of Job:
Implement day to day regulatory activities to ensure continual regulatory compliance with FDA, Notified Body, and PMDA requirements. Prepare domestic and international submissions and product registration applications to obtain regulatory approval or clearance. Implement regulatory strategies for product line extensions in support of product development team efforts, and provide guidance to these teams to ensure that development activities are consistent with overall regulatory strategy. Monitor, review and interpret new or changed regulatory requirements and proactively advise product development teams of their impact to the business. Review and approve product labeling, including marketing literature/collateral, as needed, to assure compliance with approved indications and applicable regional regulations.
Major Duties and Responsibilities:
Represent Regulatory Affairs on cross-functional product development teams; implement regulatory strategies and regulatory project timelines that ensure continued compliance with domestic and international regulations.
Prepare, review and submit domestic and international paper-based and electronic regulatory submissions, including PMA Supplement, 510(k) premarket notification, 510(k) Notes-to-File, IDE, Seihin Hyojun Sho, and Design/Technical Dossiers including associated Essential Requirements Checklists and Declarations of Conformity. Also responsible for compiling/preparing responses to questions concerning such regulatory submissions.
Prepare, review and submit annual reports to FDA (in support of a PMA or IDE). Maintain updates to the Design/Technical Dossiers for the Notified Body and Authorized Representative. Maintain updates to the Seihin Hyojun Sho for PMDA.
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 communications regarding product or process changes in advance of change notifications to affect timely approval for business objectives.
Prepare, review, 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 Company 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 Company employees changes in domestic and international regulations, issuance of new guidelines, regulations and industry standards that impact the business.
Review and approve product labeling, including marketing literature/collateral, as needed, to assure compliance with approved indications, internal procedures and applicable regulations for that country/region.
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.
Education Requirements:
Bachelors of Science degree in Life Sciences, Engineering or equivalent, or minimum five years Class III therapeutic medical device experience.
Experience Requirements:
Minimum five years direct regulatory affairs experience in the therapeutic medical device industry, with Bachelors of Science degree.
Other Qualifications:
In-depth knowledge of FDA regulations, including FDA Quality System Regulation (QSR), and EU Council Directive 93/42/EEC (MDD). Knowledgeable of Japanese Ministerial Ordinance No. 169.
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.
Individual must have demonstrated effective team leadership and organizational 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.
***This is a Direct Hire position offering 75K-95K DOE. If interested in this position, please send your resume to vfels@baysidesolutions.com
- Compensation: $75,000-$95,000
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- Please, no phone calls about this job!
- Please do not contact job poster about other services, products or commercial interests.