Boston Scientific Corporation
Senior Regulatory Affairs Specialist
Boston Scientific Corporation, Marlborough, Massachusetts, us, 01752
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 the role:
Your responsibilities will include:
Acting as company representative, developing and maintaining positive relationships with regulators through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarifications, responses to questions/inquiries, and follow-up of submissions under review
Developing and implementing regulatory strategies for new and modified products
Acting as a core member on sustaining and new product development teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions
Reviewing and approving design and manufacturing changes for existing products, ensuring compliance with applicable regulations and standard requirements
Reviewing, providing input, and approving advertising and promotional materials, as needed
Responsibilities for preparation and submission of global regulatory applications, as well as maintenance of internal regulatory file documentation
Reviewing device labeling and advertising materials for compliance with global regulations and standard requirements; analyzes and recommends appropriate changes
Solving or proposing solutions to a range of problems of varying scope and complexity through applying technical and/or functional experience or existing solutions
Logically presents information to convey key messages and complex information to others
Training to departmental and divisional policies and procedures
May lead small projects or represent Urology Regulatory Affairs on corporate teams, as needed
Fostering a work environment of continuous improvement in relation to BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility
Supporting efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing
Required qualifications:
Bachelor’s degree
3+ years of experience in Regulatory Affairs or related experiences
Understanding of regulations applicable to medical devices
Demonstrated proficiency of FDA, EU and/or international regulations
Up to 10% travel
Preferred qualifications:
Master’s Degree in a business, scientific or technical discipline
Demonstrated proficiency in understanding product development process and design controls
Experience with supporting implantable devices from a regulatory perspective
Understanding of regulations applicable to the conduct of clinical trials
Ability to manage several projects simultaneously
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
Effective research and analytical skills
Effective written and oral communication, technical writing and editing skills
Ability to work independently with minimal supervision
Requisition ID:
590670
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 identity, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.
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.
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.
Nearest Major Market:
Boston Job Segment:
Regulatory Affairs, Compliance, Urology, Advertising, Technical Writer, Legal, Healthcare, Marketing, Technology
#J-18808-Ljbffr
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 the role:
Your responsibilities will include:
Acting as company representative, developing and maintaining positive relationships with regulators through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarifications, responses to questions/inquiries, and follow-up of submissions under review
Developing and implementing regulatory strategies for new and modified products
Acting as a core member on sustaining and new product development teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions
Reviewing and approving design and manufacturing changes for existing products, ensuring compliance with applicable regulations and standard requirements
Reviewing, providing input, and approving advertising and promotional materials, as needed
Responsibilities for preparation and submission of global regulatory applications, as well as maintenance of internal regulatory file documentation
Reviewing device labeling and advertising materials for compliance with global regulations and standard requirements; analyzes and recommends appropriate changes
Solving or proposing solutions to a range of problems of varying scope and complexity through applying technical and/or functional experience or existing solutions
Logically presents information to convey key messages and complex information to others
Training to departmental and divisional policies and procedures
May lead small projects or represent Urology Regulatory Affairs on corporate teams, as needed
Fostering a work environment of continuous improvement in relation to BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility
Supporting efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing
Required qualifications:
Bachelor’s degree
3+ years of experience in Regulatory Affairs or related experiences
Understanding of regulations applicable to medical devices
Demonstrated proficiency of FDA, EU and/or international regulations
Up to 10% travel
Preferred qualifications:
Master’s Degree in a business, scientific or technical discipline
Demonstrated proficiency in understanding product development process and design controls
Experience with supporting implantable devices from a regulatory perspective
Understanding of regulations applicable to the conduct of clinical trials
Ability to manage several projects simultaneously
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
Effective research and analytical skills
Effective written and oral communication, technical writing and editing skills
Ability to work independently with minimal supervision
Requisition ID:
590670
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 identity, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.
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.
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.
Nearest Major Market:
Boston Job Segment:
Regulatory Affairs, Compliance, Urology, Advertising, Technical Writer, Legal, Healthcare, Marketing, Technology
#J-18808-Ljbffr