Reg Affairs Specialist

• Location: Cork, Farnham - Hybrid
• Req Number: 554751
• Contract type: Permanent

At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation during the recruitment process please do not hesitate to contact a member of the Talent Acquisition team for a confidential discussion.

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Purpose Statement:

Responsible for Regulatory Affairs support of the product development process, submissions, maintenance of regulatory files and regulatory compliance primarily focused on pharmaceutical products and associated ancillary products (medical devices and components) for the administration of drug product.

Roles & Responsibilities:

• Review and assess design and CMC changes, and to prepare suitable submissions to ensure compliance to pharmaceutical regulatory requirements.
• Support and provide regulatory input for pharmaceutical quality system deliverables such as batch variation summaries, customer complaints, CAPA, deviations, NCMR, etc. for the manufacturing site(s) on a daily basis.
• Prepare and submit OPDP, NDA and IND submissions and annual reports using eGateway via third party providers for USA submissions.
• Support clinical, sustaining projects and other product focused teams by giving direction on regulatory impact and requirements for proposed changes.
• Establish and maintain effective relationships and professional interactions with manufacturing sites CMC and Quality staff, third party suppliers, regulatory authority staff and reviewers.

Other responsibilities may include:

• Support filings and maintenance of regulatory files globally.
• Management of local site licenses for manufacture and importation.
• Participate in regulatory authority audits.
• Monitor regulatory landscape and communicate changes or new requirements that may impact the product or quality system.

Education & Experience:

• Degree in Life sciences (e.g., Chemistry, Biology, etc.).
• Minimum requirement of pharma industry experience from 1 to 3 years, desirable that this is in a regulatory capacity. Medical device regulatory experience desirable
• Demonstrated leadership and organizational skills.
• Understanding of commercial business.
• Demonstrated ability to handle multiple projects.
• Working knowledge of local regulations and guidelines related to drug development and registration.
• 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 and Internet resources.

About us

Purpose and Passion – Comprehensive Benefits – Life-Work Integration – Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people lives around the world. This is a place where you can find a career with meaningful purpose – improving lives through your life’s work.

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran