Pay Growth
?
out of 5
Not enough data
Not enough info to score pay or growth
Director of Regulatory Affairs
Job
ALKU
Watchung, NJ (In Person)
Full-Time
Review key factors to help you decide if the role fits your goals.
Job Security
?
out of 5
Not enough data
Calculating job security score...
Total Score
76
out of 100
Average of individual scores
Skill Insights
Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.
Job Description
Director of Regulatory Affairs at ALKU Director of Regulatory Affairs at ALKU in Watchung, New Jersey Posted in 3 days ago.
Develop, author, review, and submit regulatory applications, including 510(k)s, PMAs, and international registration dossiers, ensuring compliance with applicable regulations and standard s.
Manage regulatory submissions and communications with the U.S. FDA, international regulatory agencies, and notified bodie s.
Establish regulatory strategies for new products, design changes, and expansion into additional markets while aligning with organizational objective s.
Represent Regulatory Affairs on cross-functional teams, providing guidance on product design, testing requirements, labeling, intended use, and product claim s.
Monitor and interpret evolving regulatory requirements, guidance documents, and industry trends, translating them into practical regulatory plan s.
Provide regulatory expertise in design controls, risk management activities in accordance with ISO 14971, and clinical and non-clinical development effort s.
Evaluate product, manufacturing, and process modifications to determine regulatory impact and identify appropriate submission or documentation pathway s.
Coordinate and support interactions with regulatory authorities, including pre-submission meetings, responses to agency questions, and regulatory negotiation s.
Ensure timely and accurate responses to regulatory requests and maintain commitments made to regulatory agencie s.
Review product labeling, advertising, and promotional content to confirm alignment with regulatory requirements and approved indication s.
Support quality system activities, including CAPA investigations, change control processes, nonconformance management, and field actions from a regulatory perspectiv e.
Participate in regulatory inspections and audits, including preparation activities, inspection support, and follow-up response s.
Provide mentorship and technical guidance to regulatory team members while contributing directly to key regulatory deliverable s.
Drive continuous improvement initiatives related to regulatory processes, procedures, and best practice s. Qualificati onsBachelor's degree in Engineering, Life Sciences, or a related discipline requir ed.
Minimum of 8-10 years of Regulatory Affairs experience within a regulated industry, preferably medical devic es.
Proven experience preparing and leading 510(k) submissions from strategy through clearan ce.
Strong working knowledge of FDA regulations, international regulatory requirements, and medical device compliance framewor ks.
Experience communicating directly with regulatory agencies and notified bodi es.
Solid understanding of design controls, product development processes, and lifecycle management principl es.
Advanced degree preferr ed.
Type:
full-timeJob Description:
Director, Regulatory Affairs Position Summar yThe Director of Regulatory Affairs provides leadership and oversight for regulatory activities supporting global registrations, market access, and ongoing compliance for a medical device portfolio. This role is responsible for developing regulatory strategies, preparing and managing submissions, and ensuring regulatory requirements are effectively integrated throughout the product lifecycle. The position requires a blend of strategic leadership and hands-on execution, including direct involvement in complex regulatory submissions and interactions with health authorities . Key Responsibiliti esLead regulatory initiatives supporting product development, commercialization, and post-market activities across the product lifecycl e.Develop, author, review, and submit regulatory applications, including 510(k)s, PMAs, and international registration dossiers, ensuring compliance with applicable regulations and standard s.
Manage regulatory submissions and communications with the U.S. FDA, international regulatory agencies, and notified bodie s.
Establish regulatory strategies for new products, design changes, and expansion into additional markets while aligning with organizational objective s.
Represent Regulatory Affairs on cross-functional teams, providing guidance on product design, testing requirements, labeling, intended use, and product claim s.
Monitor and interpret evolving regulatory requirements, guidance documents, and industry trends, translating them into practical regulatory plan s.
Provide regulatory expertise in design controls, risk management activities in accordance with ISO 14971, and clinical and non-clinical development effort s.
Evaluate product, manufacturing, and process modifications to determine regulatory impact and identify appropriate submission or documentation pathway s.
Coordinate and support interactions with regulatory authorities, including pre-submission meetings, responses to agency questions, and regulatory negotiation s.
Ensure timely and accurate responses to regulatory requests and maintain commitments made to regulatory agencie s.
Review product labeling, advertising, and promotional content to confirm alignment with regulatory requirements and approved indication s.
Support quality system activities, including CAPA investigations, change control processes, nonconformance management, and field actions from a regulatory perspectiv e.
Participate in regulatory inspections and audits, including preparation activities, inspection support, and follow-up response s.
Provide mentorship and technical guidance to regulatory team members while contributing directly to key regulatory deliverable s.
Drive continuous improvement initiatives related to regulatory processes, procedures, and best practice s. Qualificati onsBachelor's degree in Engineering, Life Sciences, or a related discipline requir ed.
Minimum of 8-10 years of Regulatory Affairs experience within a regulated industry, preferably medical devic es.
Proven experience preparing and leading 510(k) submissions from strategy through clearan ce.
Strong working knowledge of FDA regulations, international regulatory requirements, and medical device compliance framewor ks.
Experience communicating directly with regulatory agencies and notified bodi es.
Solid understanding of design controls, product development processes, and lifecycle management principl es.
Advanced degree preferr ed.