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Manager I, Regulatory Affairs - Urology & Pelvic Health

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): 

Marlborough, MA, US, 01752

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

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 (Uro/PH) 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. Come join a growing, global division and become a member of a large and experienced regulatory team! https://www.linkedin.com/showcase/bsc-uroph/

 

 

Your responsibilities will include:

 

As a member of the Core Stone franchise within the Uro/PH division, you will be responsible for ongoing regulatory compliance for product development and sustaining engineering projects. You will serve as a role model in functional excellence and play a key role in the development of high potential staff who are planning, managing, and implementing regulatory submissions and supporting world-wide product registrations.


•    Directs and coordinates activities of Regulatory Affairs (RA) personnel.
•    Assists in establishing project priorities, allocating resources, and managing workloads.
•    Provides technical guidance to team in support of device change assessments, regulatory notification/submission preparation, and interaction with regulatory bodies.
•    Reviews and edits submissions prepared by team members.
•    Represents RA at management updates.
•    Formulates and implements regulatory strategies for new or modified products.
•    Collaborates cross-functionally to influence decision-making and execute problem-solving initiatives.
•    Oversees preparation and submission of global regulatory applications, including EU MDR technical documentation, as well as internal regulatory documentation.
•    Assists with developing and maintaining positive relationships with device reviewers through oral and written communications pertaining to regulatory submissions under review.
•    Oversees review of device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
•    Assists with developing and implementing departmental policies and procedures.
•    Fosters a work environment of continuous improvement in support of BSC’s Quality Policy and Quality System, as well as regulations applicable to supported products.
•    Provides training/mentoring to RA personnel as well as cross-functional partners.
•    Ensures RA personnel are appropriately trained to perform their assigned duties and such training is documented.

 

 

What we’re looking for in you:

 

Required Qualifications:


•    Minimum of a Bachelor’s degree
•    Minimum of 5 years of direct medical device Regulatory Affairs experience
•    Prior experience supervising or mentoring others
•    Strong technical knowledge of medical devices and applicable US, EU, and/or international regulations
•    Demonstrated success in management of regulatory submissions activities, including FDA and Notified Body experience
•    Demonstrated experience supporting international regulatory submissions
•    Thorough understanding of the product development process and design controls
•    Demonstrated success as the RA lead on cross-functional product development team(s)
•    Demonstrated success at writing and executing regulatory strategies for global New Product Development programs
•    Experience supporting Manufacturing/Operations driven projects and achieving change approvals globally per business expectations
•    Ability to effectively collaborate with cross-functional managers/teams to develop, influence, and execute sound strategies for regulators and the business
•    Experience supporting and assessing corrections and removals (i.e., recalls, market withdrawals, stock recoveries), field safety corrective actions, and safety alerts
•    Excellent research and analytical skills
•    Ability to manage multiple projects simultaneously
•    Excellent written and oral communication, technical writing and editing skills
•    Strong leadership, interpersonal and influencing skills
•    Ability to work independently with minimal supervision

 

 

Preferred Qualifications:


•    Bachelor’s degree in a scientific or technical discipline, or in project management
•    Master’s degree in a scientific, business, or technical discipline, or in project management
•    Prior experience managing a team
•    Prior submission experience for implants (FDA, PMDA, CFDA, ANVISA, Health Canada, TGA, etc.)
 

 

 

 

Requisition ID: 553990

 

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: Regulatory Affairs, Compliance, Project Manager, Medical Device, Technical Writer, Legal, Technology, Healthcare

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