SENIOR REGULATORY AFFAIRS SPECIALIST - Carrigtohill - Stryker Corporation

Date de publication : 11/16/2019

Résumé de l'offre

Description de l'offre


Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes.

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: Not available

Travel Percentage: None

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