Director, US Regulatory Affairs - Sequel Medical Technology
Manchester, NH
About the Job
About Sequel
Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.
Job Overview
Reporting to the Vice President, Quality & Regulatory, the US Regulatory Affairs Director is responsible for driving regulatory affairs activities for the company, in compliance with the United States regulatory requirements.
The scope of the role is expected to grow, as Sequel’s scope of activities might further evolve.
Job Responsibilities and Essential Duties
• Advise the business on US regulatory strategy to ensure products meet the latest regulatory requirements for the US market.
• Support the cross-functional teams with the implementation of the necessary tools and processes to ensure compliance with QMSR and achieve business objectives.
• Perform promotional material review and approval for the regulatory affairs function to guarantee the alignment of external communication and claims to regulatory requirements.
• On an ongoing basis, educate and train cross-functional teams on applicable FDA requirements to ensure employees understand the regulatory framework and environment.
• Responsible for securing distribution rights across various U.S. states, with a focus on obtaining specific state licenses.
• Collaborate effectively with internal and external teams to:
• Ensure successful new product launches in the United States
• Develop strategies to ensure adherence to United States regulatory requirements across the company
• Prepare the team for interactions and negotiations with the FDA, including inspections
• Participate in compliance-related activities, including field action committee engagement
• Oversee regulatory intelligence for the U.S. market by monitoring, assessing, and communicating changes in U.S. regulations and guidance documents to ensure timely actions by cross-functional teams.
Minimum Requirements
• Bachelor’s degree in life sciences preferred. Advanced degree with a focus on business or regulatory affairs strongly preferred.
• 10+ years of progressive experience in regulatory affairs, with a primary focus in medical device regulatory affairs.
Required Knowledge, Skills and Abilities
• Comprehensive knowledge of and experience with of U.S. medical device regulations, Quality Management System Regulation, and Medical Device Software. Experience with electromechanical medical devices preferred.
• Demonstrated experience successfully meeting and negotiating with the FDA.
• Demonstrated experience preparing major regulatory submissions and supportive amendments or supplements.
• Experience in the field of convenience kits is a plus.
• Demonstrated ability to build strong cross-functional relationships to drive business needs.
• Demonstrated negotiation and communication skills.
Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Environmental/Safety/Physical Work Conditions
• Ensures environmental consciousness and safe practices are exhibited in decisions
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
• May work extended hours during peak business cycles
• Physical requirements such as lifting specific weights
• Some travelling is expected
Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.
Job Overview
Reporting to the Vice President, Quality & Regulatory, the US Regulatory Affairs Director is responsible for driving regulatory affairs activities for the company, in compliance with the United States regulatory requirements.
The scope of the role is expected to grow, as Sequel’s scope of activities might further evolve.
Job Responsibilities and Essential Duties
• Advise the business on US regulatory strategy to ensure products meet the latest regulatory requirements for the US market.
• Support the cross-functional teams with the implementation of the necessary tools and processes to ensure compliance with QMSR and achieve business objectives.
• Perform promotional material review and approval for the regulatory affairs function to guarantee the alignment of external communication and claims to regulatory requirements.
• On an ongoing basis, educate and train cross-functional teams on applicable FDA requirements to ensure employees understand the regulatory framework and environment.
• Responsible for securing distribution rights across various U.S. states, with a focus on obtaining specific state licenses.
• Collaborate effectively with internal and external teams to:
• Ensure successful new product launches in the United States
• Develop strategies to ensure adherence to United States regulatory requirements across the company
• Prepare the team for interactions and negotiations with the FDA, including inspections
• Participate in compliance-related activities, including field action committee engagement
• Oversee regulatory intelligence for the U.S. market by monitoring, assessing, and communicating changes in U.S. regulations and guidance documents to ensure timely actions by cross-functional teams.
Minimum Requirements
• Bachelor’s degree in life sciences preferred. Advanced degree with a focus on business or regulatory affairs strongly preferred.
• 10+ years of progressive experience in regulatory affairs, with a primary focus in medical device regulatory affairs.
Required Knowledge, Skills and Abilities
• Comprehensive knowledge of and experience with of U.S. medical device regulations, Quality Management System Regulation, and Medical Device Software. Experience with electromechanical medical devices preferred.
• Demonstrated experience successfully meeting and negotiating with the FDA.
• Demonstrated experience preparing major regulatory submissions and supportive amendments or supplements.
• Experience in the field of convenience kits is a plus.
• Demonstrated ability to build strong cross-functional relationships to drive business needs.
• Demonstrated negotiation and communication skills.
Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Environmental/Safety/Physical Work Conditions
• Ensures environmental consciousness and safe practices are exhibited in decisions
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
• May work extended hours during peak business cycles
• Physical requirements such as lifting specific weights
• Some travelling is expected
Source : Sequel Medical Technology