Principal Reg Affairs Specialist
3 weeks ago
Principal Reg Affairs Specialist
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 extending 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 recently received PMA approval in the US. PFA technology has the potential to alter the future of ablation therapy on a global scale as we expand the reach of this product into other geographies and with different indications.
Under minimal supervision, the Principal Regulatory Affairs Specialist is responsible for developing regulatory strategy, planning, managing, and implementing regulatory approvals in the US and EU, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals.
Your responsibilities will include:
- Develops domestic and international strategies for regulatory approval of Class I, II and III medical devices
- Researches and advises company on country specific international product registration and compliance related requirements
- Coordinates, compiles, and submits U.S. 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
- Develops and maintains positive relationships with regulatory agency staff
- Technical and labeling reviews of supporting documents for inclusion in regulatory filings
- Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
- Represents RA on cross functional projects which may include product development, manufacturing process changes, site transfers, and continuous improvement efforts
- Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact
- Review and approval of marketing materials
- Lead and/or participate in regulatory audits, as required
Required qualifications:
- A minimum of a Bachelor's Degree
- A minimum of 8 years of regulatory affairs or related experience, or 5 years' experience with an advanced degree (Masters or PhD)
- Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
- Able to work independently with minimal supervision
- Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control
- Demonstrated leadership, strategic thinking, project planning, and project management skills
- 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
- 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
- Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
- 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
Requisition ID: 581430
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
-
Regulatory Affairs Specialist
1 week ago
St Paul, United States Insight Global Full timeLocation: St. Paul, MN - remote to start, but will transition to a hybrid model in the coming monthsContract: 3-12 month contract to likely hirePay: $ /hrOpenings: 1Must-haves Bachelors Degree in chemistry, biology, or other scientific/technical disciplineDatabase management skillsVery detail orientedExcellent written and verbal communication...
-
Regulatory Affairs Specialist
4 days ago
St Paul, United States Hemostasis Corp Full timeHemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, wound healing technologies, and advanced medical devices for use in the healthcare industry. We are currently seeking a Regulatory Affairs Specialist that will be able to ensure compliance with regulations. Responsibilities Include: Communicate with regulatory agencies regarding...
-
Senior Manager Regulatory Affairs
1 week ago
St Paul, United States Barrington James Full timeSenior Manager Regulatory Affairs - (Medical Device) - Hybrid in MN Our client is an, looking for a Senior Manager Regulatory Affairs with extensive experience with 510(k) submissions. As the Senior Manager Regulatory Affairs you will be the liaison for communication with US and international regulatory agencies for multiple submissions across the company....
-
PPC Regulatory Affairs Manager/BP
18 hours ago
St. Paul, United States ECOLAB Full timePharma and Personal Care - Regulatory Affairs Manager/ NA Regulatory Business Partner At Ecolab, making the world a cleaner, safer place is our business. In our Pharmaceutical & Personal Care (PPC) division, we are committed to providing complete solutions for the Pharma & Personal Care Industries. Ecolab is a company committed to growth and we believe that...
-
Regulatory Affairs Specialist
2 weeks ago
Saint Paul, Minnesota, United States Insight Global Full timeLocation: St. Paul, MN - remote to start, but will transition to a hybrid model in the coming monthsContract: 3-12 month contract to likely hirePay: $ /hrOpenings: 1Must-haves Bachelors Degree in chemistry, biology, or other scientific/technical disciplineDatabase management skillsVery detail orientedExcellent written and verbal communication...
-
Senior Regulatory Affairs Specialist
2 weeks ago
St Paul, United States Collabera Full timeJob Description Job Description · Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - Job Description suppliers should use: · Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files under review. · Assist in...
-
Principal Accounts Specialist
7 days ago
St Paul, United States University of Minnesota Full time1156 jobs found. Only the first 300 jobs can be displayed. Search Results List 300 rows List View Grid View Job Title Job ID Location Department Posted Date Job Title Accounting Supervisor Job ID 361223 Location Twin Cities Department ASR Student Finance Admin Posted Date 05/21/2024 Job Title Administrative Director Job ID 361456 ...
-
St. Paul, United States Abbott Laboratories Full timeAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...
-
St Paul, United States Ecolab Full timeThe Senior/Principal Technical Account Specialist role will give you the benefit of forming close relationships with customers and the Corporate Account sales team, but it will also provide you an opportunity to take control of the Institutional Market Test Process and create controls and procedures to provide improvements. As part of this you will help...
-
PPC Regulatory Affairs Manager/BP
2 days ago
Saint Paul, Minnesota, United States ECOLAB Full timePharma and Personal Care - Regulatory Affairs Manager/ NA Regulatory Business PartnerAt Ecolab, making the world a cleaner, safer place is our business. In our Pharmaceutical & Personal Care (PPC) division, we are committed to providing complete solutions for the Pharma & Personal Care Industries.Ecolab is a company committed to growth and we believe that...
-
Senior Regulatory Affairs Specialist
3 weeks ago
Saint Paul, United States Collabera Full timeJob DescriptionJob Description· Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - Job Description suppliers should use:· Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files...
-
Community Affairs Support Specialist
2 days ago
St Louis, United States FirstBank Full timePosition Details This role assists with coordination of a variety of activities and events for the Community Affairs department. Provides comprehensive administrative support for the Community Affairs department. Responsibilities: Maintains a basic knowledge of First Bank's policies relating to CRA and Fair Lending compliance; continue to increase...
-
Community Affairs Support Specialist
1 day ago
St Louis, Missouri, United States First Bank Full timePosition DetailsThis role assists with coordination of a variety of activities and events for the Community Affairs department. Provides comprehensive administrative support for the Community Affairs department.Responsibilities:Maintains a basic knowledge of First Bank's policies relating to CRA and Fair Lending compliance; continue to increase understanding...
-
Supervision Specialist
2 days ago
St Paul, United States Cetera Financial Group Full timeDue to the growth of our region, Cetera Wealth Partners; a region of Cetera Advisor Networks LLC, is seeking to expand its sales supervision team. The Supervision Specialist position offers a unique opportunity for a seasoned industry professional to apply their knowledge and experience while performing various business review functions in their capacity as...
-
Supervision Specialist
23 hours ago
St Paul, United States Cetera Financial Group Full timeDue to the growth of our region, Cetera Wealth Partners; a region of Cetera Advisor Networks LLC, is seeking to expand its sales supervision team. The Supervision Specialist position offers a unique opportunity for a seasoned industry professional to apply their knowledge and experience while performing various business review functions in their capacity as...
-
Regulatory Specialist
4 days ago
St Paul, United States Bell International Laboratories Full timeThe Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory requirements. Make sure...
-
Regulatory Specialist
6 days ago
St Paul, United States Bell International Laboratories Full timeThe Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory...
-
Regulatory Specialist
6 days ago
St Paul, United States Bell International Laboratories Full timeThe Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory...
-
Regulatory Specialist
3 days ago
St Paul, United States Bell International Laboratories Full timeThe Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory requirements....
-
Sr. Clinical Study Manager
3 days ago
St Paul, United States Custom Search Full timeOur small start-up client is adding a Clinical Study Manager to the team. Are you ready to join a supportive company developing a novel neuromodulation device, and to help build the clinical research infrastructure? They are growing the Clinical Affairs team (2nd person in clinical) with the addition of a (Senior/Principal) Clinical Study Manager . This role...
