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Specialist Ii, Reg Affairs
hace 2 semanas
**Work mode**:Hybrid**Onsite Location(s)**:Heredia, H, CR**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**
- 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 and has been recognized with the Catalyst Award in 2022, a prestigious recognition of diversity, equity and inclusion excellence. Also, we have a Gender Equality Policy to support our commitment.- Hybrid Roles:
- Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview.- At Boston Scientific, you’ll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden cardiac arrest. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets.**About this role**:
- This role will be responsible for working on Boston Scientific’s recently acquired novel Atrial Fibrillation technology, Pulsed Field Ablation (PFA) (FARAPULSE, Inc.). The FARAPULSE PFA System is the first PFA technology that received a CE Mark in Europe. PFA technology has the potential to alter the future of ablation therapy on a global scale as we expand the reach of this product into other geographies and with different indications. With adequate supervision, the Regulatory Affairs Specialist II is responsible for ensuring continued compliance with regulatory agency approvals through change assessments. The position may also be responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations.**Your responsibilities will include**:
- Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
- Supports requests from BSC International Regulatory related to submissions, registrations, and change assessment
- Review of technical documents, and product literature and labeling
- Represents RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
- Support regulatory audits, as required
- Support development of domestic and international strategies for regulatory approval of Class I, II and III medical devices
- Coordinate, compile, and submit 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
- Develop and maintain positive relationships with regulatory body reviewers
- Required qualifications- Minimum of a Bachelor's Degree
- Minimum of 3 years regulatory affairs or related experience
- Working knowledge of relevant US/EU regulatory requirements for medical devices including Quality Systems standards
- Effective written and oral communication, technical writing and editing skills
- Works well in fast-paced cross-functional team environments
- Preferred qualifications- Previous experience with Class II or III medical devices submissions
**Requisition ID**:568580- **Benefits - Life-Work Integration - Community - 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’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.**Job Segment**:Compliance, Regulatory Affairs, Medical Device, Law, Technical Writer, Legal, Healthcare, Technology
