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SENIOR REGULATORY AFFAIRS SPECIALIST in Carrigtohill at Stryker Corporation

Date Posted: 11/25/2018

Job Snapshot

Job Description

" Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes.

Supports the product lifecycle through to obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.

Your key responsibilities

Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.
Viewed as regulatory team resource  
Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures

Assisting in SOP development and review

Assisting in the development and update of regulatory strategy based upon regulatory changes

Providing regulatory input to new product development and product lifecycle planning

Evaluating regulatory impact of proposed changes to launched products

Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications

Determining and communicating submission and approval requirements

Participating in risk-benefit analysis for regulatory compliance

Continuing to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions

Maintaining annual licenses, registrations, and listings

Ensuring compliance with product post-approval or clearance requirements

Approving labelling, advertising and promotional items for compliance before release

Reviewing publicly disseminated information to minimize regulatory exposure

Reviewing product claims and preserving confidentiality of applicable product information

Providing regulatory input for and appropriate follow-up to inspections and audits

Reviewing change management to determine the level of change and potential submission requirements

Identifying product-associated problems and developing proposals for solutions  
Advising responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications

Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing strategies

Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements

Monitoring impact of changing regulations on submission strategies

Identifying issues early in the submission preparation process that could impact product launch

Compiling, preparing, reviewing and submitting regulatory dossiers to authorities

Participating in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance

Ability to contribute to the resolution of routine regulatory issues using sound judgment

Ability to understand and explain detailed regulatory compliance programs and/or issues

Ability to comply with constantly changing regulatory procedures and prioritize work effectively

Ability to communicate and network with regulatory personnel to obtain relevant information

What are we looking for?

B.Sc in Engineering, Sciences or equivalent preferred 1-3 years regulatory experience in the medical device or pharmaceutical industry RAC certification (preferred)  
Knowledge of the Quality System Regulations (21 CFR), Medical Device Directives (MDD) and MEDDEV guidance
Knowledge of other regulations related to Pre Market Clearance and Post Market Support Ability to work with cross functional teams   Ability to plan and conduct meetings Ability to negotiate internally and externally with FDA, NB and other regulatory bodies  
Excellent analytical and writing skills
Effective organizational skills"

Work From Home: No

Travel Percentage: None

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