Boston Scientific Corporation
Principal Regulatory Affairs Specialist - Electrophysiology Pulsed Field Ablatio
Boston Scientific Corporation, Arden Hills, Minnesota, United States,
Work mode:
Hybrid
Onsite Location(s):
Arden Hills, MN, US, 55112
Additional Location(s):
US-MN-Arden Hills
About the role:
At Boston Scientific, you’ll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden cardiac arrest. We continue to innovate in key areas and extend our products into new geographies and high-growth adjacency markets.
This role will be responsible for working on Boston Scientific’s novel Atrial Fibrillation technology, the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System was the first PFA technology that received a CE Mark in Europe and gained PMA approval in the US earlier this year. PFA technology is transforming ablation therapy on a global scale, and Boston Scientific is investing in portfolio development, robust clinical evidence, and global execution as we expand the capabilities and reach of this product with different indications.
Your responsibilities will include:
Represents RA on cross functional projects which may include product development, manufacturing process changes, site transfers, and continuous improvement efforts
Develops domestic and international strategies for regulatory approval of Class II and III electronic medical equipment devices
Coordinates, compiles, and submits US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
Supports international regulatory partners with investigational device and commercial marketing applications
Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
Technical and labeling reviews of supporting documents for inclusion in regulatory filings
Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact
Develops and maintains positive relationships with regulatory agency staff
Lead and/or participate in regulatory audits, as required
Required Qualifications:
Minimum of a Bachelor's Degree
Minimum of 7 years of regulatory affairs or related experience, or 5 years’ experience with an advanced degree (Master’s or PhD)
Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control
Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs
Strong technical, research and problem-solving skills
Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
Preferred Qualifications:
Bachelor's Degree in life sciences, engineering, or related field
Previous experience in the medical device industry with Class II or III device submissions
Experience working directly with FDA, notified bodies and/or international health authorities
Prior experience with electrophysiology and/or medical electronic equipment products
Able to work independently with minimal supervision
Demonstrated leadership, strategic thinking, project planning, and project management skills
Able to work well in fast-paced cross-functional team environments
Ability to articulate complex ideas clearly both verbally and in writing
Demonstrated ability to develop strong relationships with regulatory agency staff
Demonstrated ability to effectively lead multiple regulatory projects and priorities
Requisition ID:
593259
Nearest Major Market:
Minneapolis
Job Segment:
Regulatory Affairs, Medical Research, Clinical Research, Compliance, Medical Device, Legal, Healthcare
#J-18808-Ljbffr
Hybrid
Onsite Location(s):
Arden Hills, MN, US, 55112
Additional Location(s):
US-MN-Arden Hills
About the role:
At Boston Scientific, you’ll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden cardiac arrest. We continue to innovate in key areas and extend our products into new geographies and high-growth adjacency markets.
This role will be responsible for working on Boston Scientific’s novel Atrial Fibrillation technology, the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System was the first PFA technology that received a CE Mark in Europe and gained PMA approval in the US earlier this year. PFA technology is transforming ablation therapy on a global scale, and Boston Scientific is investing in portfolio development, robust clinical evidence, and global execution as we expand the capabilities and reach of this product with different indications.
Your responsibilities will include:
Represents RA on cross functional projects which may include product development, manufacturing process changes, site transfers, and continuous improvement efforts
Develops domestic and international strategies for regulatory approval of Class II and III electronic medical equipment devices
Coordinates, compiles, and submits US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
Supports international regulatory partners with investigational device and commercial marketing applications
Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
Technical and labeling reviews of supporting documents for inclusion in regulatory filings
Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact
Develops and maintains positive relationships with regulatory agency staff
Lead and/or participate in regulatory audits, as required
Required Qualifications:
Minimum of a Bachelor's Degree
Minimum of 7 years of regulatory affairs or related experience, or 5 years’ experience with an advanced degree (Master’s or PhD)
Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control
Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs
Strong technical, research and problem-solving skills
Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
Preferred Qualifications:
Bachelor's Degree in life sciences, engineering, or related field
Previous experience in the medical device industry with Class II or III device submissions
Experience working directly with FDA, notified bodies and/or international health authorities
Prior experience with electrophysiology and/or medical electronic equipment products
Able to work independently with minimal supervision
Demonstrated leadership, strategic thinking, project planning, and project management skills
Able to work well in fast-paced cross-functional team environments
Ability to articulate complex ideas clearly both verbally and in writing
Demonstrated ability to develop strong relationships with regulatory agency staff
Demonstrated ability to effectively lead multiple regulatory projects and priorities
Requisition ID:
593259
Nearest Major Market:
Minneapolis
Job Segment:
Regulatory Affairs, Medical Research, Clinical Research, Compliance, Medical Device, Legal, Healthcare
#J-18808-Ljbffr