Regulatory Affairs Specialist II

Work mode: Hybrid

Onsite Location(s):

Cork, IE

Additional Locations: Ireland-Galway; Ireland-Clonmel

Our Mission:

At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.

We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions and to the healthcare professionals who provide their care.

We are seeking a Regulatory Affairs Specialist II on a permanent basis to join us on our mission. Please note - This role can be based in one of our three Irish Sites (Cork, Clonmel or Galway) with a Hybrid work mode.

Job Purpose

Responsible for Regulatory Affairs support of New Product Development, product sustaining, notified body and FDA submissions, maintenance of regulatory files and regulatory compliance.

Responsibilities:

Work as part of a team responsible for regulatory activities at Boston Scientific.
Support manufacturing and design sustaining activities by assessing regulatory impact of the change, and provide guidance on regulatory strategies.
Review and approve documentation related to product changes through the change notification process.
Preparation and maintenance of Technical Documentation.
Preparation of submissions such as Annual Reports, 30 Day notices, Notice of Change etc.
Support Cork Quality function during external agency audits.
Provide regulatory support for Cork Site projects
Support strategy and submission activities for new product development.

Qualifications & Experience

Level 8 Bachelors Degree in Engineering or Life sciences (e.g., Chemistry, Biology, etc.).
Medical device regulatory experience required.
MDD / EU MDR experience required.
Demonstrated execution and organizational skills.
Demonstrated ability to handle multiple projects.
Excellent verbal and written communication skills.
Work successfully within a team environment and as an individual contributor.
Flexible and ability to adapt to changing regulatory environment and business needs.
Proficient use of technology including MS office programs

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please let us know.

Requisition ID: 587385