SENIOR REGULATORY AFFAIRS SPECIALIST in Carrigtohill at Stryker Corporation

Date Posted: 10/18/2018

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.

  • 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



  • 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: Yes

Travel Percentage: None

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