Principal Regulatory Affairs Specialist (606462)

Additional Location(s):US-MN-Maple Grove; Ireland-Cork; Ireland-Galway

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:
As the Principal Regulatory Affairs Specialist within Regulatory Operations you will play a key role in regulatory oversight and support of Peripheral Intervention (PI) medical device sustaining activities. You will spend time planning communicating and leading Regulatory Affairs (RA) initiatives to sustain PI products. Additionally you will collaborate across functions or divisions sharing your technical knowledge of regulatory requirements and influencing stakeholders to drive efficient regulatory processes in support of business growth.

This role reports to the Director Regulatory Affairs and is a hybrid position (in office minimum three days per week) located in either Maple Grove Minnesota or Cork or Galway Ireland.

Your responsibilities will include:

• Conducting Regulatory Operations activities such as:
  • Oversight of PI Postmarket Surveillance (PMS) within PI RA and serve as point-of-contact for key stakeholder groups (Design Assurance Clinical Risk etc.). This may include development and implementation of processes for maintenance of EU technical documentation / MDR Sustainment (i.e. SSCPs GSPRs etc.)
  • Support certificate activities (new/maintenance) periodic Notified Body meetings file sampling recertifications etc.
  • Help drive cadence for PMS activities periodic reviews MDR implementations End-Of-Life activities etc.
  • Chair various Regulatory forums for ongoing learning/collaboration
  • Provide regulatory training/mentoring to other RA employees and cross-functional teams
  • Identify regulatory risks/gaps in current processes needed for ongoing compliance
• Communicating effectively with PI Regulatory Affairs team leadership and other stakeholders
• Serving as an advisor and subject matter expert for ongoing EU MDR sustainment activities across PI RA
• Serving as point-of-contact for ongoing Global RA Ops initiatives needing PI Divisional support
• Developing relationships and collaborations which may enhance efficiencies growth and priorities
• Executing regulatory submissions as needed to support business needs
• Sense of urgency responsiveness and commitment to execution

Required qualifications:

• Minimum of a bachelors degree
• Minimum of 7 years experience in Regulatory Affairs or a related discipline (e.g. Quality R&D Post Market) within the medical device IVDpharmaceutical or healthcare industries
• Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards
• Prior experience with a variety of regulatory submissions for US and EU MDR
• Previous experience interacting with regulators and leading initiatives across functions divisions or sites
• Ability to travel at times up to 20%

Preferred qualifications:

• Adaptable and able to work independently with minimal supervision in a fast-changing environment
• Demonstrated leadership strategic thinking project planning and project management skills
• Excellent oral/written communicator with ability to articulate ideas transfer knowledge efficiently and effectively influence and engage colleagues
• Experience working in complex matrixed organizational structures with demonstrated capability to collaborate and influence across such an organization
• Ability to effectively lead multiple regulatory projects and priorities
• Experience working directly with FDA Notified Bodies or other regulatory agencies
• Experience with data analytics or AI tools to identify and drive operational efficiencies is a plus

#LI - Hybrid

#LI - KS

Requisition ID:606462

Minimum Salary: $99100

Maximum Salary: $188300

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see --will 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 identify 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.