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Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite)
Location:
Alpharetta, GA
Description:
Requisition ID: 5871 Job Title: Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite) Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.The Avanos COVID-19 Vaccine Policy: This Policy applies to U.S. customer-facing / field-based employees & Avanos leadership: All U.S. customer-facing / field-based employees hires must be fully vaccinated against COVID-19. Proof of being fully vaccinated does not need to be disclosed until a job offer has been made but must be submitted within 48 hours after the acceptance of the job offer. If you have a qualifying medical condition or sincerely held religious belief or practice that precludes you from receiving a COVID-19 vaccine, you may apply for an exemption or deferral after you accept the job offer and before your scheduled start date. The reasonable accommodation provided to the employee, if any, will depend on the employee's job and the applicable facts, but it may include weekly COVID-19 testing and masking requirements. New hires who do not submit, before their scheduled start date, proof of being fully vaccinated or a request for a reasonable accommodation will have their job offer revoked.Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter.We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit www.avanos.com . Job Position Purpose / Summary The Principal Specialist, Regulatory Affairs Advertising and Promotion will have accountability for review and approval of U.S. promotional and non-promotional communications of Avanos product(s).The Principal Specialist will review all Advertising and Promotional Materials to ensure Claims are in alignment with the Product's Intended Use. They will also coordinate and lead the Claims Substantiation Review Board (SRB) and maintain procedures and processes related to the review and approval of Advertising and Promotional Materials. This position requires frequent interaction and strong collaboration with cross-functional partners for the purpose of providing regulatory advice and guidance related to Advertising and Promotional Materials through the product life-cycle assuring conformity with applicable laws, regulations and Avanos policies. Job Position Accountabilities / Expectations Serve as an internal Subject Matter Expert (SME) on FDA and Global Advertising & Promotion, including scientific exchange, providing regulatory advice and offering solutions as needed Provide training as needed on Advertising and Promotional requirements, including applicable laws, regulations and Avanos policies Review and Approve all Product Advertising and Promotional Materials to confirm that the Products meet the Intended Use and to ensure that the content is truthful, accurate, fair and balanced Chair SRB Meetings including scheduling meetings, creating agendas, distributing SRB Pre-Read Materials, leading the meetings, recording and distributing the meeting minutes/follow-up action items Maintain and communicate metrics for the Claims and Copy Review Process including review and approval time and quantities Conduct Annual Audits of Copy Material Publication Logs Monitor Claims and Copy Materials for Obsolescence Arrange for Periodic Reviews and Renewals of Existing Claims and Copy Materials Initiate Obsolescence of Claims and Copy Materials that do not meet requirements Serve as the Business Process Owner (BPO) for the electronic QMS (EtQ) that houses Claims and Copy Materials, including the management of access and user requests for support Create, maintain, and update policies, procedures, work instructions related to the Claims and Copy Material processes Any other duties as assigned by management Key Relationships / Customer Expectations (Optional) Excellent verbal & written communication, conflict resolution and negotiation skills as the role will be required to interact with and influence other disciplines involved in Medical Device Advertising and Promotional review Demonstrated successful leadership experience, including developing/mentoring/coaching others and collaborating in multi-functional teams including Global Sales & Marketing (GSM), Regulatory, Legal, Clinical/Medical Affairs, Quality, Corporate Communications, and other Functional Departments Key Leadership Behaviors (Optional) Ability to work independently with minimal direction, including functional representation within teams and committees in order to attain group goals. Considered an expert within the company and may have external presence in area of expertise Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team Ability to work as part of and lead multiple teams Excellent computer skills Excellent communications, problem-solving, analytical thinking skills Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Excellent project management, strong project leadership skills Must be detail oriented and have strong organizational skills Have excellent interpersonal skills and be able to work effectively with a variety of personnel from different functional disciplines Qualifications / Education / Experience / Skills Required Experience Minimum of 10 years of experience in the Medical Device Industry or related industry Minimum of 3 years as a Regulatory Advertising and Promotional Professional Advanced knowledge of U.S. Advertising and Promotional regulations and scientific exchange provisions with proficient technical knowledge in aspects of medical device development and labeling Advanced experience with FDA promotional and regulatory review supporting product communications and/or working with FDA on Advertising and Promotional matters Experience with International Regulatory Advertising and Promotional regulations and processes (a plus, but not required) Specialized or Essential Knowledge Required (Optional) Proven track record and experience in Advertising & Promotional Review Committees/Boards with a thorough understanding of FDA guidance and regulations Physical Demands (Optional) 10% travel This document is intended to describe the general nature and level of work to be performed by employees assigned to this position. This document is not intended to be construed as a complete list of all responsibilities, duties, and skills required of incumbents. Management may at any time assign other duties in addition to those listed here, with or without modifying this position description. Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please apply here Join us at Avanos Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world. Make your career count Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits. Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting. free onsite gym | benefits on day 1 | HQ region voted 'best place to live' by USA Today Requisition ID: 5871 Job Title: Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite) Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.The Avanos COVID-19 Vaccine Policy: This Policy applies to U.S. customer-facing / field-based employees & Avanos leadership: All U.S. customer-facing / field-based employees hires must be fully vaccinated against COVID-19. Proof of being fully vaccinated does not need to be disclosed until a job offer has been made but must be submitted within 48 hours after the acceptance of the job offer. If you have a qualifying medical condition or sincerely held religious belief or practice that precludes you from receiving a COVID-19 vaccine, you may apply for an exemption or deferral after you accept the job offer and before your scheduled start date. The reasonable accommodation provided to the employee, if any, will depend on the employee's job and the applicable facts, but it may include weekly COVID-19 testing and masking requirements. New hires who do not submit, before their scheduled start date, proof of being fully vaccinated or a request for a reasonable accommodation will have their job offer revoked.Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter.We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit www.avanos.com . Job Position Purpose / Summary The Principal Specialist, Regulatory Affairs Advertising and Promotion will have accountability for review and approval of U.S. promotional and non-promotional communications of Avanos product(s).The Principal Specialist will review all Advertising and Promotional Materials to ensure Claims are in alignment with the Product's Intended Use. They will also coordinate and lead the Claims Substantiation Review Board (SRB) and maintain procedures and processes related to the review and approval of Advertising and Promotional Materials. This position requires frequent interaction and strong collaboration with cross-functional partners for the purpose of providing regulatory advice and guidance related to Advertising and Promotional Materials through the product life-cycle assuring conformity with applicable laws, regulations and Avanos policies. Job Position Accountabilities / Expectations Serve as an internal Subject Matter Expert (SME) on FDA and Global Advertising & Promotion, including scientific exchange, providing regulatory advice and offering solutions as needed Provide training as needed on Advertising and Promotional requirements, including applicable laws, regulations and Avanos policies Review and Approve all Product Advertising and Promotional Materials to confirm that the Products meet the Intended Use and to ensure that the content is truthful, accurate, fair and balanced Chair SRB Meetings including scheduling meetings, creating agendas, distributing SRB Pre-Read Materials, leading the meetings, recording and distributing the meeting minutes/follow-up action items Maintain and communicate metrics for the Claims and Copy Review Process including review and approval time and quantities Conduct Annual Audits of Copy Material Publication Logs Monitor Claims and Copy Materials for Obsolescence Arrange for Periodic Reviews and Renewals of Existing Claims and Copy Materials Initiate Obsolescence of Claims and Copy Materials that do not meet requirements Serve as the Business Process Owner (BPO) for the electronic QMS (EtQ) that houses Claims and Copy Materials, including the management of access and user requests for support Create, maintain, and update policies, procedures, work instructions related to the Claims and Copy Material processes Any other duties as assigned by management Key Relationships / Customer Expectations (Optional) Excellent verbal & written communication, conflict resolution and negotiation skills as the role will be required to interact with and influence other disciplines involved in Medical Device Advertising and Promotional review Demonstrated successful leadership experience, including developing/mentoring/coaching others and collaborating in multi-functional teams including Global Sales & Marketing (GSM), Regulatory, Legal, Clinical/Medical Affairs, Quality, Corporate Communications, and other Functional Departments Key Leadership Behaviors (Optional) Ability to work independently with minimal direction, including functional representation within teams and committees in order to attain group goals. Considered an expert within the company and may have external presence in area of expertise Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team Ability to work as part of and lead multiple teams Excellent computer skills Excellent communications, problem-solving, analytical thinking skills Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Excellent project management, strong project leadership skills Must be detail oriented and have strong organizational skills Have excellent interpersonal skills and be able to work effectively with a variety of personnel from different functional disciplines Qualifications / Education / Experience / Skills Required Experience Minimum of 10 years of experience in the Medical Device Industry or related industry Minimum of 3 years as a Regulatory Advertising and Promotional Professional Advanced knowledge of U.S. Advertising and Promotional regulations and scientific exchange provisions with proficient technical knowledge in aspects of medical device development and labeling Advanced experience with FDA promotional and regulatory review supporting product communications and/or working with FDA on Advertising and Promotional matters Experience with International Regulatory Advertising and Promotional regulations and processes (a plus, but not required) Specialized or Essential Knowledge Required (Optional) Proven track record and experience in Advertising & Promotional Review Committees/Boards with a thorough understanding of FDA guidance and regulations Physical Demands (Optional) 10% travel This document is intended to describe the general nature and level of work to be performed by employees assigned to this position. This document is not intended to be construed as a complete list of all responsibilities, duties, and skills required of incumbents. Management may at any time assign other duties in addition to those listed here, with or without modifying this position description. Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please apply here Join us at Avanos Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world. Make your career count Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits. Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting. free onsite gym | benefits on day 1 | HQ region voted 'best place to live' by USA Today PDN-9be7839e-f28c-4e13-abf4-1df44fbb1321
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Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite) is a Other Jobs Principal Specialist Regula Job at Avanos located in Alpharetta GA. Find other listings like Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite) by searching Oodle for Other Jobs Principal Specialist Regula Jobs.
Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite) is a Other Jobs Principal Specialist Regula Job at Avanos located in Alpharetta GA. Find other listings like Principal Specialist, Regulatory Affairs Advertising & Promotion (Onsite) by searching Oodle for Other Jobs Principal Specialist Regula Jobs.