More than the opportunity of a lifetime......the opportunity to improve lives 

For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine.  The Company's products help physicians and other medical professionals improve their patients' quality of life by providing alternatives to surgery.  Since 1994, employees in Galway have been at the forefront of some of these truly innovative medical device designs and manufacturing. 

Due to continued expansion of our operations, we are seeking applications from a suitably qualified and experienced Regulatory Affairs Manager II (Permanent).

Job Purpose

Responsible for multiple products and technologies. Devotes a significant portion of time to managerial, leadership and employee development responsibilities.

Key Responsibilities

• Manage EU and  international regulatory activities and issues occurring at Boston Scientific Ireland Ltd, including providing information to US based International and Domestic Regulatory Affairs groups for OUS and US submission activities. Ensures Regulatory personnel based in Intercontinental countries has the support needed to prepare and maintain submissions in various IC countries.
• Taking responsibility for regulatory activities related to new product  development and manufacturing , as well as regulatory issues relating to labeling, releases, and change management.
• In depth knowledge of the Regulatory Requirements of MDR 2017/745 to convert MDD Regulatory files to EU MDR 2017/745 requirements.
• Manage staff to complete/approve regulatory submissions including Technical files, Design Dossiers, 510k's, and PMA related submissions such as 30 Day notices, real time reviews, annual reports etc.  for all Galway products in conjunction with divisional regulatory personnel based in Maple Grove.
• Manages relationships with the Notified Bodies and acts as company representative, developing and maintaining positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow‑up of submissions under review. 
• Manage departmental procedure development and implementation.
• Provide regulatory strategies for new product introduction.
• Provide updates on regulatory requirement changes, either on individual product specification or quality systems.
• Interface with divisional DA & R&D on design change control activities, provides RA support for these functions on scoping new changes to products. 
• Assist in the preparation and the management of regulatory audits.
• Strong team member with the ability to identify and drive quality and compliance improvements.
• Good administrative / organisational ability with attention to detail is required.
• Excellent communications skills
• Establish and support a work environment of continuous improvement that supports BSC’s Quality policy, Quality System & the appropriate regulations for the area.
• Ensure employees are trained to do their work and their training is documented

Quality System Requirements

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Requirements

Bachelor's Degree with 7+ years of experience in regulatory affairs in the medical device industry with roles showing increasing responsibility OR Advanced Degree with 5+ years of experience in regulatory affairs in the medical device industry 

5+ years of leadership experience as demonstrated through direct management and/or mentorship/advisory capacity 

Preferred Qualifications

• Science / Engineering or Advanced degree desired.
• Proven track record of leading high performing teams
• Ability to recognize and develop key talent
• Site leadership setting and executing various site specific regulatory and program initiatives
• Excellent knowledge of U.S. and European/International regulations, including EU MDR, and standards for all risk classifications of products
• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Must work well in dynamic and cross functional team environments
• Must demonstrate collaboration and leadership skills in team setting including ability to coach and develop team members, and effective resource management to address multiple priorities
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
• Understanding of engineering concepts and scientific terminology.
• Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales
• Experience reviewing design specifications and other technical documents
• Superior interpersonal skills
• Excellent communication skills, both oral and written
• Documented evidence of writing skills