Senior Specialist, Regulatory Operations (Remote/Flexible)
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
The Staff Senior Specialist, Regulatory Affairs Operations, role will partner closely with Director, Regulatory Affairs Operations & Intelligence, to support regulatory intelligence activities that ensure compliance of new and currently marketed products, taking into consideration current and proposed changes in regulatory requirements and standards globally. Providing support to administrative registration... activities to facilitate timely regulatory submissions and market authorization/approvals.
Responsibilities
Responsible to work collaboratively with local (US & Canada), International (EMEA, Eurasia, APAC & LatAM) Regulatory teams, and other cross-functional stakeholders to implement regulatory policies, processes & procedures, systems, and reporting mechanisms/tools in compliance with global regulatory requirements ensuring alignment with overall business strategic goals/priorities.
Lead continuous improvement projects for standard operating processes for regulatory affairs and other functional intersecting processes within the organization.
Proactively keep abreast of changes in global laws, regulations, standards/guidance and assess their impact and make recommendations to ensure compliance and provide regular reporting across the organization on key developments that impact product and/or processes and/or business directly. Lead cross-functional initiatives with research development, operations, and sustainability on regulatory intelligence updates
Review and approve global advertising/promotional material
Provide administrative support for registration activities to facilitate timely regulatory submissions and market authorization/approvals.
Manage and keep up to date information regarding regulatory submissions and registrations.
Maintaining templates and style guides for regulatory submissions
Actively support regulatory and quality teams for any internal and external audits/assessments that may require access to regulatory records, information, or reports.
Manage and submit global establishment, device listings and renewals.
Maintain the archives for regulatory authority communications, commitments, submissions, and registrations.
Support global regulatory submissions as needed
Required Skills and Competencies
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction. Communicates changes and progress.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares
expertise with others. Demonstrated experience and proficiency with the Microsoft Office products (Word, Excel, PowerPoint, Access, Outlook)
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
English read/write fluency a MUST. A second global language is a plus.
Excellent ability to generate and maintain accurate records.
Required Interpersonal Skills & Behaviors
Ethics - Treats people with respect; Ability to be honest and trustworthy; Works with integrity and ethically; Upholds organizational values.
Teamwork - Balances team and individual responsibilities; Integrates continuous feedback loops; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit. Shares expertise with others.
Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Education and Experience
B.S./B.A. (4-year Degree) and/or an equivalent combination of education and experience/background in life sciences, technical (engineering) or related field.
RAPS (RAC) Certification is preferred.
5+ years of Medical Device Regulatory Affairs experience.
Working knowledge of International Regulations (e.g., US FDA 21 CFR 820, EU MDR 2017/745 and IMDRF/GHTF) required.
Experience with regulatory data management systems preferred.
Additional Information
The position can be remote, hybrid or in-person at any of our Insulet locations.
Travel is estimated at 10% but will flex depending on business needs.
NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote
Additional Information:
The US base salary range for this full-time position is $105,000.00 - $157,800.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
(Know Your Rights
Apply Now
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
The Staff Senior Specialist, Regulatory Affairs Operations, role will partner closely with Director, Regulatory Affairs Operations & Intelligence, to support regulatory intelligence activities that ensure compliance of new and currently marketed products, taking into consideration current and proposed changes in regulatory requirements and standards globally. Providing support to administrative registration... activities to facilitate timely regulatory submissions and market authorization/approvals.
Responsibilities
Responsible to work collaboratively with local (US & Canada), International (EMEA, Eurasia, APAC & LatAM) Regulatory teams, and other cross-functional stakeholders to implement regulatory policies, processes & procedures, systems, and reporting mechanisms/tools in compliance with global regulatory requirements ensuring alignment with overall business strategic goals/priorities.
Lead continuous improvement projects for standard operating processes for regulatory affairs and other functional intersecting processes within the organization.
Proactively keep abreast of changes in global laws, regulations, standards/guidance and assess their impact and make recommendations to ensure compliance and provide regular reporting across the organization on key developments that impact product and/or processes and/or business directly. Lead cross-functional initiatives with research development, operations, and sustainability on regulatory intelligence updates
Review and approve global advertising/promotional material
Provide administrative support for registration activities to facilitate timely regulatory submissions and market authorization/approvals.
Manage and keep up to date information regarding regulatory submissions and registrations.
Maintaining templates and style guides for regulatory submissions
Actively support regulatory and quality teams for any internal and external audits/assessments that may require access to regulatory records, information, or reports.
Manage and submit global establishment, device listings and renewals.
Maintain the archives for regulatory authority communications, commitments, submissions, and registrations.
Support global regulatory submissions as needed
Required Skills and Competencies
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction. Communicates changes and progress.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares
expertise with others. Demonstrated experience and proficiency with the Microsoft Office products (Word, Excel, PowerPoint, Access, Outlook)
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
English read/write fluency a MUST. A second global language is a plus.
Excellent ability to generate and maintain accurate records.
Required Interpersonal Skills & Behaviors
Ethics - Treats people with respect; Ability to be honest and trustworthy; Works with integrity and ethically; Upholds organizational values.
Teamwork - Balances team and individual responsibilities; Integrates continuous feedback loops; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit. Shares expertise with others.
Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Education and Experience
B.S./B.A. (4-year Degree) and/or an equivalent combination of education and experience/background in life sciences, technical (engineering) or related field.
RAPS (RAC) Certification is preferred.
5+ years of Medical Device Regulatory Affairs experience.
Working knowledge of International Regulations (e.g., US FDA 21 CFR 820, EU MDR 2017/745 and IMDRF/GHTF) required.
Experience with regulatory data management systems preferred.
Additional Information
The position can be remote, hybrid or in-person at any of our Insulet locations.
Travel is estimated at 10% but will flex depending on business needs.
NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote
Additional Information:
The US base salary range for this full-time position is $105,000.00 - $157,800.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
(Know Your Rights
Apply Now