Reg Affairs Specialist II - CRM

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.

Reg Affairs Specialist II - CRM

You'll discover a place where you can have meaningful purpose, improving lives through your life's work. Our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets.

In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure, and protecting against sudden cardiac arrest. In addition, we offer solutions with 3D Mapping and Navigation systems, Radiofrequency Ablation catheters, Diagnostic Catheters, EP recording systems, and Intracardiac Access Sheaths. Boston Scientific develops, manufactures, and markets a broad array of products and services that enable less-invasive care for some of the most threatening cardiac conditions. We've been expanding indications and conducting pivotal research for nearly 20 years, resulting in increased access to the lifesaving and life-enhancing benefits of ICD and CRT therapies.

About the role:

Under supervision, the Regulatory Affairs Specialist II is responsible for planning, managing, and implementing regulatory approvals to the FDA, notified body and other country specific product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals.

Your responsibilities will include:

• Researches and advises company on country specific international product registration and compliance related requirements
• Coordinates, compiles, and submits US and international regulatory filings for new and modified products, including IDEs, PMAs, PMA supplements, IDE periodic reports, PMA annual reports, CE Mark dossiers and updates, and other country specific product registrations
• Reviews test protocols and reports for inclusion in regulatory filings
• Assesses labeling, advertising, and promotional materials for regulatory compliance and support of claims
• Reviews product and manufacturing changes for compliance with applicable regulations and impact to regulatory filing
• Represents RA on cross functional product development and manufacturing support teams
• Works with clinical affairs on various aspects of clinical trials and clinical reports

Required qualifications:

• Minimum of a bachelor's degree in life sciences, engineering, or related field
• Minimum of 3 years regulatory experience

Preferred qualifications:

• Working knowledge of regulatory requirements for medical devices
• Effective written and oral communication and technical writing skills
• Basic writing and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
• Experience with Class II or Class III medical devices submissions
• Experience with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
• Experience working directly with FDA, notified bodies and/or international health authorities
• Strong technical, research, problem-solving, and leadership skills
• Ability to communicate complex ideas clearly and simply both orally and in writing
• Demonstrated ability to effectively lead multiple projects and priorities
• Team player with excellent interpersonal skills

Requisition ID:586865

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 (NYSE: BSX) 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!

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran's status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance freeworkplace. 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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.