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Manager I, Regulatory Affairs Operations - Cardiac Rhythm Management 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 in Country
Onsite Location(s): 

Arden Hills, MN, US, 55112

Additional Location(s): US-MN-Arden Hills; US-MA-Boston; US-MA-Cambridge; US-MA-Marlborough; US-MA-Natick; US-MA-Quincy; US-MN-Maple Grove; US-MN-Minneapolis; 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.

 

 

Team Purpose: The Rhythm Management (RM) Regulatory Affairs Operations team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle.

 

This role is considered part of the RM RA Leadership team. This role will manage and provide leadership to regulatory submission publishers and operations specialists. This role will support shared services related to US and EU regulatory submission publishing, regulatory-owned CAPAs, and distribution controls. This role will also be responsible for representing RM regulatory interests within assigned corporate and global regulatory initiatives, quality system projects, continuous improvement projects, process ownership and audit support. Additionally, this role will be responsible to manage assigned RM RA IT solutions. 

 

Key Responsibilities:


•    Lead RM Regulatory Affairs Operations team in a matrixed organization.  
•    Encourages and facilitates professional development of direct reports.
•    Hires, evaluates, and trains direct reports.
•    Coordinates with RM Management in establishing project priorities, allocating resources and workload.
•    Develops and utilizes relationships, tools, processes and other resources to assist in solving problems and gain efficiencies through Reg operations initiatives
•    Collaborate with Reg leadership to develop efficiency tools/processes to better manage functional activities (i.e., Change management, distribution controls, periodic reporting, IT system support, business process support).
•    Supports Quality System and audit readiness through data maintenance and compliance checks of owned processes.
•    Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support.  

 

Required Qualifications:


•    Minimum of a Bachelor’s degree 
•    Minimum of 4 years’ experience working under a quality system or a related discipline (e.g., Project Management, Quality Systems, R&D, Post Market, Operation Management) 
•    Prior experience leading and/or managing others
•    Excellent written and oral communication
•    Excellent research and analytical skills
•    Ability to manage multiple projects simultaneously 
•    Proven leadership, collaboration and influencing skills 
•    Ability to collaborate with cross-functional partners/teams
•    Ability to work independently with minimal supervision 
•    Demonstrated success as the lead on cross-functional teams
•    Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint)

 

Preferred Qualifications:


•    Experience with lean processing 
•    Working knowledge of FDA, EU and/or international medical device regulations or experience in similar regulated industry/environments
•    Experience with audits from government bodies (e.g., FDA, MDSAP, ISO 13485)
•    Ability to read and interpret regulations and standards
•    General understanding of product development process, design controls and quality system regulations
 

 

 

 

Requisition ID: 530042

 

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: Medical, Operations Manager, Manager, Cardiac, Healthcare, Operations, Management

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