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Regulatory Affairs Specialist I

4 months ago

Marlborough, United States Boston Scientific Corporation Full time

**Work mode**:Hybrid**Onsite Location(s)**:Marlborough, MA, US, 01752**Additional Location(s)**: N/A**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.**About this role**:
As a part of the Rhythm Management division, the Regulatory Affairs Specialist works to deliver advanced, life-saving and sustaining technologies to patients worldwide. Under direct supervision, the incumbent will help plan, implement, and manage regulatory submissions to the US FDA and EU notified bodies, while supporting global product registrations and change impact reviews to ensure continued compliance with regulatory agency approvals.- We provide innovative solutions for diagnosing and treating heart conditions, while constantly advancing in crucial areas and expanding our reach into new markets and regions. Joining the Digital Health and Cardiac Diagnostics Regulatory team at Boston Scientific CRM means you’ll play a pivotal role in delivering cutting-edge technologies that preserve and save lives across the globe. In this role, you are encouraged to be curious, develop and employ creative thinking skills, and will have the opportunity to satisfy your desire to learn about emerging technologies and their impacts on the business and organization.**Your responsibilities will include**:

- Supporting the development of global strategies for regulatory approval of Class I, II and III medical devices
- Coordinating, compiling, and submitting U.S. and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
- Assisting with BSC International regulatory requests regarding submissions, registrations, and change assessments; develop and manage relationships with regulatory representatives
- Reviewing product and manufacturing changes to ensure compliance with applicable regulations and impact to regulatory filings
- Supporting regulatory audits as needed
- Reviewing promotional materials for regulatory compliance
- Representing Regulatory Affairs on cross-functional projects such as product development, manufacturing process changes, and continuous improvement
- Assisting with departmental projects such as procedure stewardship, Value Improvement Projects (VIP), and Regulatory Operations initiatives
- Keeping abreast of emerging technologies and potential impacts on the business and organization

**Required Qualifications**
- Bachelor’s degree in life science, computer science, engineering or related disciplines
- Experience working with cross-functional teams

**Preferred Qualifications**
- Relevant coursework, work-study, or internship experience with US, EU, and international regulatory requirements for medical devices and quality systems standards
- Familiar with medical device software
- Effective presentation and communication skills (written and verbal) Ability to work effectively as an individual and as part of a team; ability to recognize and consider varying perspectives**Requisition ID**:583121- At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why 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 maintains a prohibited substance free workplace. Pursuant to Va. Code - 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.-
**Nearest Major Market**:Boston
**Job Segment**:Regulatory Affairs, Compliance, Medical Device, Law, Computer Science, Legal, Healthcare, Technology