Med Device Manufacturing - Regulatory Affairs & Quality Lead 8/26/2016
Diedre Moire Corporation, Inc
JOB DESCRIPTIONAPPLY Seeking Regulatory Affairs and QualitySystem expertise in Medical Device manufacturing and a track record supporting and improving a quality and results driven company culture with excellent regulatory compliance and continually improving operations to support and coordinate registration, device licensing, surveillance, adverse event and corrective action reporting, translation, product standards, and other activities.
*** Interface with FDA, Notified Body, and other external regulatory representatives relating to: Audits, Vigilance, Medical Device Reporting, 510(k) filings, license renewals, establishment registrations, etc.
*** Generally conduct activities to support Regulatory Affairs management with the company's compliance to FDA QualitySystem Regulations, ISO 13485 and related (US and International) regulations and requirements.
*** Prepares regulatory submissions and supplements, such as 510Ks, PMAs, IDE, ANDA, etc.), and device listings.
*** Plan and manage the regulatory path and requirements for the introduction of products to the market.
*** Prepare and maintain Technical Documentation Files (EU Tech Files and Design Dossiers, prepare Export Certificates (CFGs, CFS, etc.)
*** Participate in design control activities.
*** Maintain required regulatory records and track and control submissions.
*** Review and advise on labeling for compliance with regulatory filings.
*** Review product changes for impact on regulatory filings.
*** Research regulatory issues and provide guidance and advice to management.
Generous compensation package with competitive salary and bonuses, company paid health and wellness benefits. Company matched 401(k), profit sharing, stock options, and pension. Vacation time from start with paid time off for personal days, sick days, and holidays. Upwards mobility and chance to directly impact the success and growth of the organization.
Please reference #36899144 when responding.
Education Requirements: Bachelor Degree
Minimum Experience Requirements: 2-5 years
Job City Location: Putnam
Job State Location: CT
Job Country Location: USA
Salary Range: $70,000 to $110,000
WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs.