Additional Location(s):US-MN-Maple Grove; US-MA-Marlborough; US-MN-Arden Hills; 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: Global RA Ops is a group of SMEs that advocate for the Regulatory function and connect our partners to solutions, services, and data that enable them to efficiently and predictably gain and maintain market access worldwide.
Responsible to support and manage the global regulatory affairs operations for Boston Scientific. This role will primarily support, build, and implement programs and initiatives designed to improve the overall effectiveness of the Regulatory Affairs function. Devotes a significant portion of time to managerial, leadership, and employee development responsibilities as well as support the overall vision and goals of the Director of Global RA Operations and the team.
This person will also be the Quality System Steward responsible for Regulatory Approvals and Regulatory Approvals Maintenance sub-processes. Within that role, this person will have responsibility for representing regulatory interests within quality system projects and process changes, process ownership, and audit support.
This position will have the following responsibilities:
* Perform as Process Steward for Regulatory Product Approvals and Maintenance processes per BSC's quality system
* Manage team members primarily focused on continuous improvements, creation of global processes for the overall Regulatory Affairs function and input in cross functional process changes to ensure the needs of the Regulatory Affairs function are considered
* Provide leadership and supporting the global regulatory operations vision, strategy and objectives
* Partner with cross divisional team members and business unit and country regulatory affairs to identify process gaps and opportunities for efficiencies. Then, initiate and lead projects to address needs.
* Partner with global counterparts to ensure various geographical implementation of local laws are incorporated or aligned with global RA processes and procedures
* Actively participate in various Quality System Community of Practice teams by providing technical and strategic input and representing Regulatory Affairs interests, assessing impact, and bringing awareness to Regulatory Teams.
* Author, revise and edit standard operating procedures and work instructions.
* Lead assessments for global requirement changes and collaborate with cross-functional partners to influence changes to the quality system as needed.
* Represent function in audit settings by presenting regulatory processes and evidence of compliance in collaboration with the Quality Systems group.
* Supports specific RA operational and/or CAPA activities which are cross-divisional or regional for the regulatory function.
* Leads and mentors team members' project priorities, resource allocation, workload, and escalation of team's challenges to the Global RA Ops Director
* Drives an overall customer centric and collaborative culture
* Minimum of a Bachelor's degree or equivalent work experience
* Minimum of 7 years' experience in Regulatory Affairs or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) within the medical device, IVD, pharmaceutical or healthcare industries
* Minimum of 2 years managing direct reports
* Working knowledge of FDA, EU and/or international medical device regulations
* Experience with audits from regulatory bodies (e.g. MDSAP and ISO 13485)
* Ability to read and interpret global regulations and standards
* General understanding of product development process, design controls and quality system regulations
* Proficiency with Microsoft Office applications (Teams, Word, Excel, Powerpoint)
* Degree or work experience in a scientific or technical discipline
* Excellent written and oral communication, technical writing and editing skills
* Excellent research and analytical skills
* Ability to manage multiple projects
* Proven leadership, collaboration and influencing skills
* History of participating in process improvement initiatives
* Willingness to travel to divisions, regions, and corporate headquarters (estimate 10% travel in non-pandemic conditions)
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.