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Manager II, Regulatory Affairs - Electrophysiology

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:  Hybrid
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-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.

 

 

Purpose Statement:


The Regulatory Affairs Manager II supports the Electrophysiology (EP) Franchise goals through leadership of the EP Regulatory Affairs (RA) team. Leadership of the team includes cross-functional coordination and influence, employee development, managing team resources to support franchise priorities, and support of day-to-day regulatory activities and responsibilities.
 

 

 

Key Responsibilities:


•    Directs and coordinates activities of RA employees, including direct supervision and development of team.
•    Establishes and manages project priorities, allocating resources and workload to achieve business milestones.
•    Participates in advocacy/outreach with Senior franchise and functional leaders to achieve business objectives and assess potential commercialization pathways.
•    Collaborates with peers within the EP Franchise including PMO, R&D, Clinicals, Manufacturing, and other functions across multiple sites to influence and gain alignment needed to achieve business objectives in the most efficient/effective manner. 
•    Provides regulatory expertise with respect to global regulatory strategy development, execution, and risk management.
•    Provides regulatory expertise to facilitate entry into new therapeutic areas, technologies, and newly regulated regions and emerging markets.
•    Drives clarity into product approval and post market requirements through effective problem identification, communication, and use of regulatory agency network.
•    Supports staff in their day-to-day activities, such as regulatory team lead on projects, assessing regulatory impact of changes, developing, and executing global regulatory strategy, and drafting EU and US submissions. 
•    Collaborates with RA functional peers from across BSC to establish procedures and best practices to optimally utilize RA talent.
•    Supports Quality System and Internal and External audits.
•    Supports Product Investigations and Field Action activities.
•    Performs regulatory due diligence on candidate companies and products/programs; provides initial regulatory project management for integration of new companies and products into the EP franchise; assesses RA resource needs and supports new employee integration.
•    Researches competitive product regulatory approvals and pathways, and disseminates to relevant stakeholders.
•    Provides litigation support, including research and depositions.

 

 

Required Qualifications


•    A minimum of a Bachelor’s degree 
•    A minimum of 7 years of experience in regulatory affairs or related field in the Medical Device industry
•    Minimum of 2 years of experience directly managing a team 
•    Demonstrated success with coaching and development of a team 
•    Demonstrated ability to learn new cross-functional areas of medical device industry  
•    Ability to effectively partner cross-functionally 
•    Ability to successfully manage multiple projects simultaneously
•    Excellent written and oral communication
•    Strong leadership, interpersonal and influencing skills
•    Ability to work independently and prioritize workload with minimal supervision 
•    Excellent research and analytical skills
•    Proficiency with Microsoft Office

 

 

Preferred Qualifications


•    Knowledge of EP products
•    Understanding of EU, US, and/or global medical device regulations
•    Previous experience with EU, US, and/or global regulatory submission activities 
•    Previous experience with the support of clinical studies
 

 

 

 

Requisition ID: 553406

 

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.

 

 

RSRBSC


Nearest Major Market: Minneapolis

Job Segment: Regulatory Affairs, Compliance, Law, Clinical Research, Medical Research, Legal, Healthcare

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