Regulatory Affairs Specialist II

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.

Advancing possibilities for a brighter tomorrow

Boston Scientific is seeking a highly motivated Regulatory Affairs Specialist II on a permanent basis to join our team.

Job Purpose:

You will be 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.

Key Responsibilities:

• Review and assess design and CMC changes, and 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).
• 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.
• Support filings and maintenance of regulatory files globally.
• Management of local site licenses for manufacture and importation.
• Participate in regulatory authority inspections and 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 1-3years, ideally in a regulatory capicity.
• 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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers

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 email TalentAcquisitionIre@bsci.com