Boston Scientific
Principal Regulatory Affairs Specialist
Boston Scientific, Osseo, Minnesota, United States, 55311
Overview
Join to apply for the
Principal Regulatory Affairs Specialist
role at
Boston Scientific .
Additional Location(s): US-MN-Maple Grove
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.
About This Role This role, within the Peripheral Interventions division, is responsible for a wide variety of catheter, balloon, and implantable products that support Boston Scientific’s Clot Management and Carotid Therapy businesses. This includes strategic support of Boston Scientific’s Transcarotid Artery Revascularization (TCAR) technologies. TCAR is a cutting-edge, comprehensive carotid artery disease therapy designed for stroke prevention while exposing patients to less risk and pain. This role provides opportunity to gain regulatory experience in US, China, Japan, and other international regions.
This is a hybrid role based in Maple Grove, Minnesota, requiring employees to be in our local office at least three days per week.
Your Responsibilities
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 medical devices. This includes strategies for gaining CE Mark under EU MDR
Coordinates, compiles, and submits US regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports
Supports international regulatory partners with commercial marketing applications and post-market studies
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
7+ years of experience in Regulatory Affairs, or 5+ years of experience with an advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline
Demonstrated leadership, strategic thinking, project planning, and project management skills
Demonstrated ability to assess the impact of global regulatory requirements on projects and determine strategy to ensure cost, schedule, and performance requirements are met on multiple projects
Demonstrated ability to apply regulatory knowledge across multiple projects and communicate long term implications of regulatory, clinical, marketing and business strategies for global product commercialization
Ability to influence and negotiate product development strategies and product approvals with global regulatory bodies
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 MDR Technical Documentation
Strong technical, research and problem-solving skills
Basic submission and presentation related computer skills, including experience with 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
Able to work independently with minimal supervision
Demonstrated ability to mentor junior regulatory staff members to aid in their development
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 610311
Salary 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 www.bscbenefitsconnect.com – 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).
Legal and Diversity Notice Boston Scientific Corporation is an equal opportunity employer. It is the policy of the Company to recruit, hire, train, and promote people without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, disability, or any other protected class. Boston Scientific will comply with all applicable state and federal law and healthcare credentialing requirements. Some US-based positions may require proof of COVID-19 vaccination status; candidates will be notified during the interview and selection process if vaccination is required.
Company Overview As a leader in medical science for more than 40 years, Boston Scientific is 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. We are an equal opportunity employer and value inclusion and diversity.
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Principal Regulatory Affairs Specialist
role at
Boston Scientific .
Additional Location(s): US-MN-Maple Grove
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.
About This Role This role, within the Peripheral Interventions division, is responsible for a wide variety of catheter, balloon, and implantable products that support Boston Scientific’s Clot Management and Carotid Therapy businesses. This includes strategic support of Boston Scientific’s Transcarotid Artery Revascularization (TCAR) technologies. TCAR is a cutting-edge, comprehensive carotid artery disease therapy designed for stroke prevention while exposing patients to less risk and pain. This role provides opportunity to gain regulatory experience in US, China, Japan, and other international regions.
This is a hybrid role based in Maple Grove, Minnesota, requiring employees to be in our local office at least three days per week.
Your Responsibilities
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 medical devices. This includes strategies for gaining CE Mark under EU MDR
Coordinates, compiles, and submits US regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports
Supports international regulatory partners with commercial marketing applications and post-market studies
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
7+ years of experience in Regulatory Affairs, or 5+ years of experience with an advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline
Demonstrated leadership, strategic thinking, project planning, and project management skills
Demonstrated ability to assess the impact of global regulatory requirements on projects and determine strategy to ensure cost, schedule, and performance requirements are met on multiple projects
Demonstrated ability to apply regulatory knowledge across multiple projects and communicate long term implications of regulatory, clinical, marketing and business strategies for global product commercialization
Ability to influence and negotiate product development strategies and product approvals with global regulatory bodies
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 MDR Technical Documentation
Strong technical, research and problem-solving skills
Basic submission and presentation related computer skills, including experience with 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
Able to work independently with minimal supervision
Demonstrated ability to mentor junior regulatory staff members to aid in their development
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 610311
Salary 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 www.bscbenefitsconnect.com – 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).
Legal and Diversity Notice Boston Scientific Corporation is an equal opportunity employer. It is the policy of the Company to recruit, hire, train, and promote people without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, disability, or any other protected class. Boston Scientific will comply with all applicable state and federal law and healthcare credentialing requirements. Some US-based positions may require proof of COVID-19 vaccination status; candidates will be notified during the interview and selection process if vaccination is required.
Company Overview As a leader in medical science for more than 40 years, Boston Scientific is 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. We are an equal opportunity employer and value inclusion and diversity.
#J-18808-Ljbffr