W. L. Gore & Associates, Inc.
Labeling and Post-Market Surveillance Regulatory Affairs Associate - Remote
W. L. Gore & Associates, Inc., Elkton, Maryland, us, 21922
About the Role
We are looking for a Labeling and Post-Market Surveillance Regulatory Affairs associate to join our Regulatory Excellence team. In this role, you will provide strategic regulatory support across the product lifecycle, with a focus on labeling and post-market compliance for Class II and Class III implantable medical devices. You will collaborate cross-functionally to ensure global regulatory requirements are effectively integrated into product content and surveillance systems. Your contributions will shape regulatory best practices, support global submissions, and drive continuous improvement in regulatory processes and systems.
This is a remote position, and you can work from home in most locations within the United States.
Responsibilities
Identify and continuously monitor the global regulatory and customer requirements for labeling of implantable medical devices
Identify and continuously monitor the global regulatory requirements for post-market surveillance of implantable medical devices
Collaborate with cross-functional teams to strategize and implement relevant global labeling and post-market surveillance regulatory requirements into content in accordance with the quality system
Provide Regulatory Affairs quality system support of cross-product line activities for labeling and post-market surveillance (e.g. change orders, quality plans, protocols and reports)
Provide expertise in global regulatory strategy development for labeling and post-market surveillance
Prepare, write, coordinate, and interactively follow up on global submissions related to labeling for implantable medical devices
Coordinate with applicable stakeholders to develop responses to requests from regulatory authorities regarding labeling and post-market surveillance
Provide regulatory direction and active support for the development and/or use of standardized best practices, processes and tools
Identify regulatory opportunities for training, system enhancements, and process harmonization
Assist in internal and external quality system audits and develop strategic responses and corrective actions to audit findings
Required Qualifications
Bachelor's degree
Minimum of 3 years of experience working in a medical-device and/or pharmaceutical industry role directly involved in the application of regulations and standards
Working knowledge of global directives and regulations with regards to labeling and post-market surveillance for Class II and III implantable medical devices
Strong communication skills (oral, written, and interpersonal skills) adaptable to circumstance and audience
Demonstrated ability to organize and complete complex projects on time and in compliance with requirements
Demonstrated ability to influence in a complex, cross-functional organization
Ability to prioritize work and adapt to shifting priorities
Ability to work independently with limited supervision
Desired Qualifications
Bachelor's degree in engineering, biological, chemical, medical, or allied health sciences field
Demonstrated experience in adopting global regulatory requirements into quality system standards, specifications, or procedures
Experience with electronic labeling and company website requirements
This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore's work arrangement policies.
Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island.
What We Offer Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing".
Learn more at gore.com/careers/benefits. Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
Gore requires all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
#J-18808-Ljbffr
This is a remote position, and you can work from home in most locations within the United States.
Responsibilities
Identify and continuously monitor the global regulatory and customer requirements for labeling of implantable medical devices
Identify and continuously monitor the global regulatory requirements for post-market surveillance of implantable medical devices
Collaborate with cross-functional teams to strategize and implement relevant global labeling and post-market surveillance regulatory requirements into content in accordance with the quality system
Provide Regulatory Affairs quality system support of cross-product line activities for labeling and post-market surveillance (e.g. change orders, quality plans, protocols and reports)
Provide expertise in global regulatory strategy development for labeling and post-market surveillance
Prepare, write, coordinate, and interactively follow up on global submissions related to labeling for implantable medical devices
Coordinate with applicable stakeholders to develop responses to requests from regulatory authorities regarding labeling and post-market surveillance
Provide regulatory direction and active support for the development and/or use of standardized best practices, processes and tools
Identify regulatory opportunities for training, system enhancements, and process harmonization
Assist in internal and external quality system audits and develop strategic responses and corrective actions to audit findings
Required Qualifications
Bachelor's degree
Minimum of 3 years of experience working in a medical-device and/or pharmaceutical industry role directly involved in the application of regulations and standards
Working knowledge of global directives and regulations with regards to labeling and post-market surveillance for Class II and III implantable medical devices
Strong communication skills (oral, written, and interpersonal skills) adaptable to circumstance and audience
Demonstrated ability to organize and complete complex projects on time and in compliance with requirements
Demonstrated ability to influence in a complex, cross-functional organization
Ability to prioritize work and adapt to shifting priorities
Ability to work independently with limited supervision
Desired Qualifications
Bachelor's degree in engineering, biological, chemical, medical, or allied health sciences field
Demonstrated experience in adopting global regulatory requirements into quality system standards, specifications, or procedures
Experience with electronic labeling and company website requirements
This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore's work arrangement policies.
Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island.
What We Offer Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing".
Learn more at gore.com/careers/benefits. Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
Gore requires all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
#J-18808-Ljbffr