GatedTalent Connecting Top Executive Search Firms And Executives
Head of Regulatory Affairs – Remote USA
GatedTalent Connecting Top Executive Search Firms And Executives, Boston, Massachusetts, us, 02298
What You’ll Do
Regulatory Strategy Development: Leading the development and execution of regulatory strategies, identifying preferable market/s from which to operate, and to ensure the company’s readiness for compliance with relevant national and international regulations. There should be a focus on enabling market access for the company in the Brain-Computer Interface (BCI) space.
Regulatory Advocacy and Thought Leadership: Leading or participating in regulatory agency interactions. Engaging with relevant regulatory authorities, industry bodies, collaborative communities, and policymakers to shape the regulatory landscape for biotech, advocating for policies that promote innovation while ensuring patient safety.
Policy Analysis and Guidance: Provide analysis on global regulatory policies, and advise executive leadership on potential regulatory risks and opportunities, while driving initiatives to influence regulatory frameworks as well as monitoring for change across regulations to ensure proactive compliance.
Product development: Provide premarket regulatory strategy guidance as part of the product and product development processes to comply with regulatory requirements for early feasibility, first-in-human, investigational use, and clinical trials across multiple jurisdictions. This includes advising on risk assessments, biocompatibility and safety evaluations for Class 2a/2b and Class 3 active implantable medical devices, as well as the compilation of submission dossiers, management of breakthrough, TAP, and other available regulatory acceleration programs.
Regulatory approval process: Oversee regulatory approval processes, including US FDA pre-market approval (PMA) and 510(k) submissions, as well as manage relationships with national regulators and policy-makers in alternative and frontier markets.
Cross-functional Leadership: Collaborate with internal teams (e.g., R&D, legal, compliance) in both the company and with our partners to ensure alignment with regulatory requirements and to proactively address emerging regulatory challenges in the biotech industry.
Regulatory Oversight: Advising on post-approval compliance and ensuring ongoing adherence to regulatory requirements and continued market access, including post-market approval monitoring, safety reporting, and product modifications.
Requirements:
Minimum of 10 years regulatory experience in medical technology regulation, with a strong background in neurotechnology and implantable devices (Class 2a and 2b or Class 3).
Proven ability to interact effectively with US and international regulators, including the FDA. Experience with PMA processes, 510(k) submissions, and clinical trials. Experience in successfully completing De Novo Classification Requests.
Ability to apply knowledge of key regulatory frameworks in the U.S. and internationally (e.g. FDA, EMA Global Health Authority, ICH guidelines) both strategically and operationally and provide direction to resolve complex regulatory issues.
Added to the above, a demonstrated ability and appetite to apply the above knowledge in frontier / alternative markets such as Latin America as part of developing equivalent clinical or pre-clinical trials in other jurisdictions globally.
Experience across the process to obtain necessary approvals for applications and products, specifically for Class 2a/2b and Class 3 active implantable medical devices.
Expertise in preparing complex regulatory documents and other major regulatory submissions, including the preparation and execution of interactions with regulatory authorities, in particular for scientific advice and approvals for clinical trials.
Communication: Exceptional communication skills, both written and verbal, with experience in public speaking and representing companies in regulatory discussions.
Must be a strong team player, and willing to be fully engaged with key stakeholders both in the company but also with our partners. Must have hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills
Additional Skills:
Fluency in a second language is a plus, notably Spanish.
Experience working in smaller / startup companies, having an appreciation for their limitations and unique operating environments is highly desirable.
A strong scientific and technical background, ideally with experience in the medical technology space, including working knowledge of neurotechnology, gene therapies, or similar fields.
#JPKR
#JPKR
#J-18808-Ljbffr
Regulatory Strategy Development: Leading the development and execution of regulatory strategies, identifying preferable market/s from which to operate, and to ensure the company’s readiness for compliance with relevant national and international regulations. There should be a focus on enabling market access for the company in the Brain-Computer Interface (BCI) space.
Regulatory Advocacy and Thought Leadership: Leading or participating in regulatory agency interactions. Engaging with relevant regulatory authorities, industry bodies, collaborative communities, and policymakers to shape the regulatory landscape for biotech, advocating for policies that promote innovation while ensuring patient safety.
Policy Analysis and Guidance: Provide analysis on global regulatory policies, and advise executive leadership on potential regulatory risks and opportunities, while driving initiatives to influence regulatory frameworks as well as monitoring for change across regulations to ensure proactive compliance.
Product development: Provide premarket regulatory strategy guidance as part of the product and product development processes to comply with regulatory requirements for early feasibility, first-in-human, investigational use, and clinical trials across multiple jurisdictions. This includes advising on risk assessments, biocompatibility and safety evaluations for Class 2a/2b and Class 3 active implantable medical devices, as well as the compilation of submission dossiers, management of breakthrough, TAP, and other available regulatory acceleration programs.
Regulatory approval process: Oversee regulatory approval processes, including US FDA pre-market approval (PMA) and 510(k) submissions, as well as manage relationships with national regulators and policy-makers in alternative and frontier markets.
Cross-functional Leadership: Collaborate with internal teams (e.g., R&D, legal, compliance) in both the company and with our partners to ensure alignment with regulatory requirements and to proactively address emerging regulatory challenges in the biotech industry.
Regulatory Oversight: Advising on post-approval compliance and ensuring ongoing adherence to regulatory requirements and continued market access, including post-market approval monitoring, safety reporting, and product modifications.
Requirements:
Minimum of 10 years regulatory experience in medical technology regulation, with a strong background in neurotechnology and implantable devices (Class 2a and 2b or Class 3).
Proven ability to interact effectively with US and international regulators, including the FDA. Experience with PMA processes, 510(k) submissions, and clinical trials. Experience in successfully completing De Novo Classification Requests.
Ability to apply knowledge of key regulatory frameworks in the U.S. and internationally (e.g. FDA, EMA Global Health Authority, ICH guidelines) both strategically and operationally and provide direction to resolve complex regulatory issues.
Added to the above, a demonstrated ability and appetite to apply the above knowledge in frontier / alternative markets such as Latin America as part of developing equivalent clinical or pre-clinical trials in other jurisdictions globally.
Experience across the process to obtain necessary approvals for applications and products, specifically for Class 2a/2b and Class 3 active implantable medical devices.
Expertise in preparing complex regulatory documents and other major regulatory submissions, including the preparation and execution of interactions with regulatory authorities, in particular for scientific advice and approvals for clinical trials.
Communication: Exceptional communication skills, both written and verbal, with experience in public speaking and representing companies in regulatory discussions.
Must be a strong team player, and willing to be fully engaged with key stakeholders both in the company but also with our partners. Must have hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills
Additional Skills:
Fluency in a second language is a plus, notably Spanish.
Experience working in smaller / startup companies, having an appreciation for their limitations and unique operating environments is highly desirable.
A strong scientific and technical background, ideally with experience in the medical technology space, including working knowledge of neurotechnology, gene therapies, or similar fields.
#JPKR
#JPKR
#J-18808-Ljbffr