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Principal 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; Argentina-Buenos Aires; Australia-NSW-Mascot; Austria-Graz; Austria-Innsbruck; Austria-Klagenfurt am Wörthersee; Austria-Krem an der Donau; Austria-Linz; Austria-Salzburg; Austria-Vienna; Austria-Wien; Barbados-Bridgetown; Belgium-Diegem; Brazil-AC-Rio Branco; Brazil-AL-Maceió; Brazil-AM-Manaus; Brazil-AP-Macapá; Brazil-BA-Salvador; Brazil-CE-Fortaleza; Brazil-DF-Brasília; Brazil-ES-Vitória; Brazil-GO-Goiânia; Brazil-MA-São Luís; Brazil-MG-Belo Horizonte; Brazil-MS-Campo Grande; Brazil-MT-Cuiabá; Brazil-PA-Belém; Brazil-PB-João Pessoa; Brazil-PE-Recife; Brazil-PI-Teresina; Brazil-PR-Curitiba; Brazil-RJ-Rio de Janeiro; Brazil-RN-Natal; Brazil-RO-Porto Velho; Brazil-RR-Boa Vista; Brazil-RS-Porto Alegre; Brazil-SC-Chapeco; Brazil-SC-Florianópolis; Brazil-SE-Aracaju; Brazil-SP-São Paulo; Brazil-TO-Palmas; Bucharest-Romania; Canada-AB-Calgary; Canada-AB-Edmonton; Canada-AB-Northern Alberta; Canada-AB-Southern Alberta; Canada-BC-Capitol Region & Island; 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Netherlands-Arnhem; Netherlands-Eindhoven; Netherlands-Kerkrade; Netherlands-Kerkrade; Netherlands-Maastricht; Netherlands-Nieuwegein; Netherlands-Rotterdam; Netherlands-Rotterdam; Netherlands-Utrecht; New Zealand-Auckland; Norway-Asker; Peru-Lima; Philippines-Pasig City; Poland-Bialystok; Poland-Bydgoszcz/Toruń; Poland-Gdańsk; Poland-Gorzów Wielkopolski/Zielona Góra; Poland-Katowice; Poland-Kielce; Poland-Kraków; Poland-Lublin; Poland-Olsztyn; Poland-Opole; Poland-Poznań; Poland-Rzeszów; Poland-Szczecin; Poland-Warsaw; Poland-Wrocław; Poland-Łódź; Portugal-Coimbra; Portugal-Faro; Portugal-Lisboa; Portugal-Oporto; Puerto Rico-Dorado; Puerto Rico-San Juan; Russia-Ekaterinburg; Russia-Kazan; Russia-Krasnodar; Russia-Moscow; Russia-Novosibirsk; Russia-Saint-Petersburg; Russia-Samara; Russia-Sochi; Russia-Stavropol; Russia-Ufa; Saudi Arabia-Riyadh; Singapore-Singapore; South Africa-Eastern Cape; South Africa-Free State; South Africa-Gauteng; South Africa-Johannesburg; South Africa-KwaZulu-Natal; South Africa-Limpopo; South Africa-Mpumalanga; South Africa-North West; South Africa-Northern Cape; South Africa-Western Cape; Spain-Barcelona; Spain-Bilbao; Spain-Granada; Spain-La Coruña; Spain-Madrid; Spain-Malaga; Spain-Sevilla; Spain-Valencia; Spain-Zaragoza; Sweden-Helsingborg; Switzerland-Aarau; Switzerland-Basel; Switzerland-Bellinzona; Switzerland-Bern; Switzerland-Chur; Switzerland-Ecublens; Switzerland-Genf; Switzerland-Konstanz; Switzerland-Lausanne; Switzerland-Locarno; Switzerland-Lugano; Switzerland-Luzern; Switzerland-Montreux; Switzerland-Neuenburg; Switzerland-Solothurn; Switzerland-St. Gallen; Switzerland-Thun; Switzerland-Winterthur; Switzerland-Zürich; Taiwan-Taipei City; Thailand-Bangkok; Turkey-Ankara; Turkey-Gaziantep; Turkey-Istanbul; Turkey-Izmir; Turkey-Kocaeli; Turkey-Samsun; US-AK-Anchorage; US-AK-Fairbanks; US-AK-Juneau; US-AL-Anniston; US-AL-Auburn; US-AL-Birmingham; US-AL-Mobile/Dothan; US-AL-Montgomery; US-AL-Northern/Huntsville; US-AL-Tuscaloosa; US-AR-Eastern; US-AR-Fayetteville; US-AR-Fort Smith; US-AR-Little Rock; US-AZ-Flagstaff; US-AZ-Phoenix; US-AZ-Tucson; US-AZ-Yuma; US-CA-Anaheim/Huntington Beach; US-CA-Campbell; US-CA-Carlsbad; US-CA-Central Coast; US-CA-Central Valley; US-CA-Chico/Eureka; US-CA-Fremont; US-CA-Irvine; US-CA-Laguna Hills; US-CA-Long Beach; US-CA-Los Angeles; US-CA-Los Gatos; US-CA-Menlo Park; US-CA-Mountain View; US-CA-North Bay; US-CA-Oakland/East Bay; US-CA-Orange County; US-CA-Sacramento; US-CA-San Bernardino/Palm Springs; US-CA-San Bruno; US-CA-San Clemente; US-CA-San Diego; US-CA-San Francisco; US-CA-San Jose; US-CA-Santa Barbara; US-CA-Santa Rosa; US-CA-Silicon Valley; US-CA-Sunnyvale; US-CA-Valencia; US-CA-Ventura County; US-CO-Boulder/Fort Collins; US-CO-Colorado Springs; US-CO-Denver; US-CO-Denver South; US-CO-Western/Grand Junction; US-CT-Danbury/Bridgeport; US-CT-Hartford; US-CT-New Haven; US-CT-Southeast/New London; US-CT-Stamford; US-DC-Washington; US-DE-Delaware; US-FL-Daytona; US-FL-Ft. Lauderdale; US-FL-Ft. Myers/Naples; US-FL-Gainesville/Ocala; US-FL-Jacksonville; US-FL-Melbourne; US-FL-Miami; US-FL-Orlando; US-FL-Pensacola/Panama City; US-FL-St. Petersburg; US-FL-Tallahassee; US-FL-Tampa; US-FL-West Palm Beach; US-GA-Alpharetta; US-GA-Atlanta; US-GA-Central/Augusta; US-GA-Macon; US-GA-Savannah; US-GA-Southwest; US-HI-Hawaii; US-IA-Cedar Rapids; US-IA-Central/Des Moines; US-IA-Davenport; US-IA-Western/Sioux City; US-ID-Boise; US-ID-Idaho Falls/Pocatello; US-ID-Northern; US-ID-Twin Falls; US-IL-Bloomington/Peoria; US-IL-Chicago; US-IL-Quincy; US-IL-Rockford; US-IL-Southern; US-IL-Springfield/Champaign; US-IN-Evansville; US-IN-Fort Wayne; US-IN-Gary/Merrillville; US-IN-Indianapolis; US-IN-Lafayette; US-IN-South Bend; US-IN-Spencer; US-IN-Terre Haute; US-KS-Kansas City; US-KS-Overland Park; US-KS-Topeka/Manhattan; US-KS-Wichita Western; US-KY-Bowling Green/Paducah; US-KY-Lexington; US-KY-Louisville; US-LA-Alexandria; US-LA-Baton Rouge; US-LA-Lafayette/Lake Charles; US-LA-New Orleans; US-LA-Northern; US-LA-Shreveport; US-MA-Bedford; US-MA-Boston; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester; US-MD-Baltimore; US-MD-Columbia; US-MD-Hunt Valley; US-MD-Montgomery County; US-MD-Rockville; US-MD-Salisbury; US-ME-Central/Augusta; US-ME-Northern/Bangor; US-ME-Southern/Portland; US-MI-Ann Arbor; US-MI-Detroit; US-MI-Flint/Saginaw; US-MI-Grand Rapids; US-MI-Kalamazoo; US-MI-Lansing; US-MI-Northern; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Northern/Duluth; US-MN-Plymouth; US-MO-Jefferson City; US-MO-Kansas City/Independence; US-MO-Northeastern; US-MO-Quincy; US-MO-Southeastern; US-MO-Springfield/Joplin; US-MO-St. Louis; US-MS-Central; US-MS-Northern; US-MS-Southern; US-MT-Eastern/Billings; US-MT-Great Falls; US-MT-Helena/Butte; US-MT-Western/Missoula; US-NC-Charlotte; US-NC-Eastern/Greenville; US-NC-Greensboro; US-NC-Raleigh/Durham; US-NC-Western/Asheville; US-NC-Wilmington/Fayetteville; US-NC-Winston Salem; US-ND-Central; US-ND-Eastern; US-ND-Valley City; US-ND-Western; US-NE-Lincoln; US-NE-Omaha; US-NE-West/North Platte; US-NH-Northern; US-NH-Southern; US-NJ-Central; US-NJ-Northern; US-NJ-Southern; US-NM-Albuquerque; US-NM-Santa Fe; US-NV-Las Vegas; US-NV-Reno; US-NY-Albany/Poughkeepsie; US-NY-Binghamton/Elmira; US-NY-Buffalo; US-NY-Glens Falls; US-NY-Long Island; US-NY-New York City; US-NY-Northern; US-NY-Rochester/Pittsford; US-NY-Syracuse; US-NY-Utica; US-NY-Westchester; US-OH-Akron; US-OH-Cincinnati; US-OH-Cleveland; US-OH-Columbus/Zanesville; US-OH-Dayton; US-OH-Northwest; US-OH-Toledo; US-OH-Youngstown; US-OK-Central-Oklahoma City; US-OK-Eastern/Tulsa; US-OR-Central; US-OR-Portland; US-OR-Salem; US-OR-Southern; US-PA-Allentown; US-PA-Altoona; US-PA-Erie; US-PA-Harrisburg; US-PA-Philadelphia; US-PA-Pittsburgh; US-PA-State College; US-PA-Wilkes Barre; US-PA-York/Lancaster; US-RI-Coventry; US-RI-Providence; US-SC-Columbia; US-SC-Florence/Myrtle Beach; US-SC-Greenville/Spartanburg; US-SC-South/Charleston; US-SD-East/Sioux Falls; US-SD-West/Rapid City; US-TN-Chattanooga; US-TN-Jackson; US-TN-Knoxville; US-TN-Memphis; US-TN-Nashville; US-TX-Abilene/Odessa; US-TX-Amarillo/Lubbock; US-TX-Austin; US-TX-Dallas; US-TX-East/Tyler/Beaumont; US-TX-El Paso; US-TX-Fort Worth; US-TX-Houston; US-TX-San Antonio; US-TX-South/Corpus Christi; US-TX-Waco; US-TX-Wichita Falls; US-UT-Provo; US-UT-Salt Lake City; US-VA-Alexandria; US-VA-Charlottesville/Harrisonburg; US-VA-Fairfax; US-VA-McLean/Arlington; US-VA-Norfolk/Hampton Roads; US-VA-Northern; US-VA-Richmond; US-VA-Roanoke; US-VA-Vienna; US-VT-Northern; US-VT-Southern; US-WA-Bellevue/Redmond; US-WA-Central/Yakima; US-WA-Eastern/Spokane; US-WA-Seattle; US-WA-Tacoma/Olympia; US-WI-Eau Claire/LaCrosse; US-WI-Green Bay/Appleton; US-WI-Madison; US-WI-Milwaukee; US-WI-Northern; US-WV-Northern; US-WV-Southern; US-WY-Casper; US-WY-Cheyenne; United Arab Emirates-Algeria; United Arab Emirates-Dubai; United Arab Emirates-Egypt : Cairo; United Arab Emirates-Riyadh; United Kingdom-Aberdeen; United Kingdom-Ashford; United Kingdom-Backburn; United Kingdom-Barnsley; United Kingdom-Barnsley; United Kingdom-Basildon; United Kingdom-Basingstoke; United Kingdom-Bath; United Kingdom-Bedford; United Kingdom-Birkenhead; United Kingdom-Birmingham; United Kingdom-Blackpool; United Kingdom-Bolton; United Kingdom-Bournemouth; United Kingdom-Bradford; United Kingdom-Bradford; United Kingdom-Brighton; United Kingdom-Bristol; United Kingdom-Camberley; United Kingdom-Cambridge; United Kingdom-Canterbury; United Kingdom-Cardiff; United Kingdom-Carlisle; United Kingdom-Chelmsford; United Kingdom-Cheltenham; United Kingdom-Chester; United Kingdom-Colchester; United Kingdom-Coventry; United Kingdom-Crawley; United Kingdom-Darlington; United Kingdom-Derby; United Kingdom-Doncaster; United Kingdom-Dundee; United Kingdom-Eastbourne; United Kingdom-Edinburgh; United Kingdom-Exeter; United Kingdom-Farnham; United Kingdom-Glasgow; United Kingdom-Gloucester; 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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.

 

 

The Urology and Pelvic Health business unit provides proven, leading solutions to treat five common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), male incontinence and pelvic floor disorders. These conditions account for 50 percent of all urology surgical procedures.  Additionally, we continue to invest in SpaceOAR™ Hydrogel to help minimize the potential side effects of radiation therapy. Come join a growing, global division and become a member of a large and experienced regulatory team! https://www.linkedin.com/showcase/bsc-uroph/

 

 

Job Purpose:

 

Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for MDR, product development process and sustaining engineering projects.

 

 

 Key Responsibilities:

 

•    Provides oversight of Notified Body submissions and responses, driving consistency in approach and passing on knowledge from previous submissions/responses. Reviews and collaborates with responsible regulatory specialist, design, clinical, and manufacturing teams on submissions/ responses to questions from EU regulatory bodies related to compliance to the EU Medical Device Regulation. 
•    Communicates trends from UroPH Notified Body feedback to the entire UroPH Regulatory Affairs team and prepares guidance/training in response. 
•    Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
•    Directs and coordinates activities for small team of Regulatory Affairs specialists
•    Assists in establishing project priorities, allocating resources, and workload
•    Responsible for preparation and submission of global regulatory applications, EU Post Market Surveillance Reporting submissions, SSCP, as well as internal regulatory file documentation.
•    Develops and implements regulatory strategies for projects that cross across UroPH franchises, such as manufacturing site transfers or regulation changes.
•    Acts as a core member providing regulatory feedback and guidance throughout the product and manufacturing process development cycle and coordinating team inputs for submissions.
•    Reviews and approves design and manufacturing changes for cross franchise programs, ensuring compliance with applicable regulations.
•    Lead and/or participate in regulatory audits, as required
•    Trains to departmental and divisional policies and procedures.
•    Fosters a work environment of continuous improvement in support of BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility.
•    Supports efforts to improve collaboration, knowledge sharing, and best practices within the department and division.

 

 

Required Qualifications:

 

•    Minimum of a Bachelor’s degree or equivalent work experience
•    Minimum of 8 years’ experience in Medical Device Regulatory Affairs experience, or a minimum of 5 years’ experience in Medical Device Regulatory Affairs and a minimum of 3 years of experience in a related discipline (e.g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility) within medical device industry
•    Prior submission experience including MDR Design Dossier and Tech File reviews with Notified Bodies, PMA/510(k) and international
•    Thorough understanding of US, EU and/or international regulations for medical devices
•    Thorough understanding of product development process and design controls
•    Ability to manage several regulatory projects

 

 

Preferred Qualifications:


 
•    Professional certification(s) and/or Master’s degree preferred
•    Effective written and oral communication, technical writing and editing skills
•    Excellent research and analytical skills
•    Ability to work independently with minimal supervision
•    Strong technical knowledge of medical devices, procedures, practices, and related terminology
•    Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
•    General understanding of regulations applicable to conduct of clinical trials
•    General understanding of standards applicable to medical devices
•    Prior experience working with Notified Bodies on substantial changes, and management of Design Dossier renewals preferred
 

 

 

Requisition ID: 527501

 

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.


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