Manager, Regulatory Affairs Urology

Additional Location(s):US-MA-Marlborough

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role:
At Boston Scientific our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets.

The Urology business unit provides proven leading solutions to treat common urology diseases including kidney stones benign prostatic hyperplasia (BPH) erectile dysfunction (ED) male incontinence and pelvic floor disorders.

This role within theStone franchise will be responsible for supporting existing product lines developing new technologies driving value improvement initiatives and managing CAPAs. The role also includes managerial and leadership responsibilities with a focus on employee development and cross-functional collaboration.

Work model sponsorship:
At Boston Scientific we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:
Direct and coordinate activities of Regulatory Affairs employees.
Assist in establishing project priorities and allocating resources and workload.
Provide technical guidance to the team during submission preparation and regulatory interactions.
Review and edit submissions prepared by team members.
Represent Regulatory Affairs in management updates and discussions.
Develop and implement short-range regulatory strategy.
Execute regulatory strategies for new and modified products including single-use devices implants and medical electrical equipment.
Drive departmental best practices for regulatory processes.
Deliver Regulatory Affairs training and mentoring to employees.
Develop and maintain positive relationships with regulatory reviewers through clear effective communication.
Oversee preparation and submission of global regulatory applications and maintain internal regulatory documentation.
Review labeling and advertising materials for compliance and recommend necessary changes.
Assist in developing physician and patient labeling.
Review and sign off on product and manufacturing changes for regulatory compliance.
Provide CAPA support to the regulatory team and cross-functional partners.
Promote a continuous improvement environment that aligns with Boston Scientifics Quality Policy and System.
Ensure employee training is documented and compliant with quality standards.

Management responsibilities:
Lead a team in achieving organizational goals.
Guide coach direct and develop direct reports; promote these practices across the organization.
Foster a diverse inclusive environment that enables all team members to contribute fully.
Ensure compliance with company policies and applicable regulations.
Provide regulatory guidance on management teams.

Qualifications:

Required qualifications:
Bachelors degree preferably in a scientific technical or project management discipline
Minimum of 7 years experience in Regulatory Affairs or a related field within the medical device industry
Demonstrated success in managing regulatory submissions including FDA and Notified Body experience
Demonstrated success serving as the Regulatory Affairs lead on large cross-functional development teams
Experience supporting manufacturing or operations-driven projects and achieving global change approvals
Submission experience for single-use implantable and medical electrical equipment products (e.g. FDA PMDA CFDA ANVISA Health Canada TGA)
Strong technical knowledge of medical products
Deep understanding of the product development process and design control
Strong technical understanding of regulatory procedures and relevant medical terminology
Excellent research and analytical skills
Ability to manage multiple projects independently
Excellent written and oral communication technical writing and editing skills

Preferred qualifications:
Management experience
International regulatory experience
Strong leadership and interpersonal skills
Influencing and cross-functional collaboration skills
Ability to work independently with minimal supervision
Strategic thinking and ability to influence product direction

#LI-Hybrid

Requisition ID:622220

Minimum Salary: $106800

Maximum Salary: $202900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training pertinent education including licensure and certifications among other relevant business or organizational needs. At BSC it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly) non-sales roles may also include variable compensation from time to time (e.g. any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt non-sales roles may also include variable compensation i.e. annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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) isnt just business its personal. And if youre 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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy the Company will continue to take steps to assure that recruitment hiring assignment promotion compensation and all other personnel decisions are made and administered without regard to race religion color national origin citizenship sex sexual orientation gender identity gender expression veteran status age mental or physical disability genetic information or any other protected class.

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 Companys policies or protocols change with regard to COVID-19 vaccination.