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Manager II, Regulatory Affairs - Cardiac Rhythm Management

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 in Country
Onsite Location(s): 

Arden Hills, MN, US, 55112

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

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.

 

 

Regulatory Subject Matter Expert (SME) on multiple products, technologies and regions.  Devotes time on the day-to-day regulatory activities which includes oversight, regulatory guidance, and hands-on submission or other regulatory responsibilities. Also devotes a portion of time to managerial, leadership and employee development responsibilities.
 

 

Key Responsibilities:


•    Provides regulatory expertise with respect to global regulatory strategy development, execution and risk management.
•    Directs and coordinates activities of Regulatory Affairs employees, including direct supervision of related team.
•    Establishes and manages project priorities, allocating resources and workload to achieve business milestones.
•    Participates in advocacy/outreach with Sr. franchise and functional leaders to achieve business objectives and assess commercialization pathway trade-offs.
•    Provides regulatory expertise to facilitate entry into new therapeutic areas, technologies and design; and new regulated regions such as emerging markets.
•    Drives clarity into product approval and post market requirements through effective problem identification, communication and use of regulatory agency network.
•    Operates effectively as regulatory team lead on assigned projects including global regulatory strategy development and execution.
•    Assesses and manages global dependencies and opportunities to coordinate regulatory efforts serving as liaison to both regional BSC RA personnel and Agencies, and internal functional and program management stakeholders.
•    Capable of authoring and executing / supporting all aspects of Global Regulatory Strategies and submissions. Provides regulatory expertise and assessment for product and manufacturing changes. 
•    Collaborates with Regulatory Affairs functional peers from across BSC to establish procedures and best practices optimally utilizing our Regulatory Affairs talent
•    Supports New Business Development by performing regulatory due diligence on candidate companies and products/programs; provides initial regulatory project management for integration of new companies and products into the CRV franchise structure; assesses RA resource needs and supports staffing and new employee integration as needed; acts as RA Core Team Member for Alliance and/or acquired PDP programs.
•    Leads regulatory-related education efforts and mentoring in areas of expertise.
•    Studies and understand applicability of relevant regulations to the business.
•    Researches competitive product regulatory approvals and pathways, and disseminates to relevant stakeholders.
•    Provides litigation support, including research and depositions.
•    Supports Quality System and audit readiness through maintenance and provision of regulatory information to QA, Notified Bodies and FDA.
 

 

Required Qualifications:


•    A minimum of a Bachelor’s degree is required 
•    A minimum of 7 years of experience in regulatory affairs in the Medical Device industry
•    Demonstrated ability to lead and manage others, either through projects or direct management
•    Demonstrated success in the management of regulatory submissions activities, such as 510k, IDE, PMA, and EU MDD and MDR CE Marking
•    Understanding of MDR EU Regulations
•    Understanding of global regulatory requirements
•    Ability to effectively partner cross-functionally to develop and influence sound regulatory strategies
•    Understanding of clinical strategies and real-world evidence
•    Previous experience with the support of clinical studies and/or real-world evidence strategies

•    Excellent research and analytical skills
•    Ability to successfully manage multiple projects simultaneously
•    Excellent written and oral communication, technical writing, and editing skills
•    Strong leadership, interpersonal and influencing skills
•    Proficiency with Microsoft Office
•    Ability to work independently and prioritize workload with minimal supervision 

 

 

Preferred Qualifications:


•    Experience with Diagnostics is preferred
•    Exposure to Independent Diagnostic Test Facilities is desired
•    Strong knowledge of Cardiology products
•    Experience with integrations
•    Experience with Breakthrough Designation
 

 

 

 

Requisition ID: 540653

 

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: Minneapolis

Job Segment: Regulatory Affairs, Compliance, Law, Technical Writer, Clinical Research, Legal, Technology, Healthcare

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