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Sr. Specialist, Regulatory Affairs - Urology & Pelvic Health Job

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Remote Global
Onsite Location(s): 

Marlborough, MA, US, 01752

Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove

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.

 

 

At Boston Scientific, you’ll discover a place where you can find meaningful purpose, improving lives through your life's work.  We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. This position is in the Urology and Pelvic Health business of Boston Scientific and is specifically focused on the integration of the Lumenis LTD Surgical business that was acquired in September 2020.   The Lumenis surgical business includes premier laser system, fibers and accessories for urology and otolaryngology procedures.

 

About the role:

 

This position's main contribution is to provide support to the regulatory integration activities.                                        

 

Your responsibilities may include:


•    Support the integration of Lumenis by coordinating conversion of all labeling to BSC as the Legal Manufacturer.Support the Regulatory team with US and EU MDR planning and submission activities. Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
•    Complete regulatory assessments for design and process changes and coordinates and manages product distribution controls to set up and define rules for all required product control.
•    Assists manufacturing and development teams, providing regulatory feedback and guidance throughout the product integration for any product changes, and coordinating team inputs for submissions.
•    Assists the Regulatory team with UDI data entry and upload. Proficient in Excel to create, manage and coordinate required regulatory information fields for required device listings.
•    Work with International counterparts on registration/license transfer and regulatory requirements.
•    Assists teams to migrate advertising and promotional material into BSC processes/systems.
•    May assist professional and technical staff with special projects.
•    Provide data and information to other functions on processes and procedures, as requested.
•    Uses software for functional area, to compile and generate reports, statistics, timelines, tables, graphs, correspondence and presentations.
•    May design processes to enhance work flow.
•    Provides data and information to others on functional unit processes and procedures.
 

 

What we’re looking for in you:

 

Required Qualifications:


•    A minimum of a Bachelor’s degree or equivalent combination of education and experience 
•    A minimum of 5 years’ experience in Regulatory Affairs in the medical device, pharmaceutical, and/or health care industries
•    Extensive knowledge in specialized applications such as Regulatory Safety Nets, Legal Status controls, and Regis database
•    Experience in Capital equipment and knowledge in electrical, safety and radio frequency standards 
•    Proficiency with Microsoft Office, (i.e. creating formulas, v look up, pivot tables and working with multiple worksheets in Excel; using captions, cross references and inserting graphics, charts and tables in Word; creating forms, queries and reports in Access)
•    General understanding of product development process documents, international standards and urology disease state products
•    Ability to manage several projects simultaneously
•    Effective research and analytical skills
•    Effective written and oral communication, technical writing and editing skills
•    Ability to work independently with minimal supervision
•    Periodic travel to Israel

 

Preferred Qualifications:


•    Degree in a scientific or technical discipline

 


 

 

Requisition ID: 527764

 

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 is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-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: Medical, ENT, Regulatory Affairs, Electrical, Law, Healthcare, Legal, Engineering

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