BD (Tissuemed Ltd)
Sr. Regulatory Affairs Specialist
BD (Tissuemed Ltd), San Jose, California, United States, 95199
Job Title
Senior Regulatory Affairs Specialist – San Milpitas, CA Job Description Summary
BD Life Sciences is recruiting for a Senior Regulatory Affairs Specialist in San Milpitas, CA. The Sr. Regulatory Affairs Specialist will be responsible for the preparation and approval of regulatory submissions required to market new or modified in vitro diagnostic devices as well as research use only (RUO) products in global markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. It also requires identifying required documentation, management of submission to worldwide RA partners and working with cross functional teams to ensure that all data and information required for regulatory submissions and approvals are generated. Responsibilities
Manage the regulatory process by interacting directly with country RA partners and government agencies; provide updates on status of applications submitted to appropriate internal stakeholders; coordinate meetings between relevant departments when necessary; oversee submission package preparation including compilation of documentation required under applicable law or regulation; review draft documents prepared by others prior to submission; prepare correspondence regarding outcomes of submissions; respond promptly to queries received during evaluation period; liaise effectively between internal departments & external authorities throughout entire lifecycle of application until final decision has been made; participate actively in negotiations where required; contribute meaningfully towards resolution of any issues raised by authorities during evaluation phase so that timely decisions can be reached without unduly delaying progress toward ultimate goal – successful commercialization of products within targeted markets globally. Collaborate closely with internal functions such as Marketing, Sales, Technical Support etc., to understand customer needs better; identify potential areas where improvements could be made to enhance overall performance of existing products; develop strategies aimed at maximizing opportunities for growth through innovative solutions designed specifically around those requirements; leverage expertise gained via experience working across multiple disciplines to drive forward initiatives which benefit both organization and customers alike. Monitor changes in legislation relating to medical device industry; stay abreast of emerging trends affecting regulatory landscape globally; keep up-to-date records of key events occurring within sector; identify implications arising from new policies implemented by governments; assess impact on current operations; devise plans accordingly so as to not disrupt normal functioning of business units. Conduct regular audits to ensure compliance with relevant regulations governing medical devices; identify gaps if any exist between actual practices employed by organization versus standards set forth by authorities; implement corrective measures swiftly whenever deficiencies are detected. Work collaboratively with internal stakeholders such as R&D, Quality Control, Manufacturing etc., to gather information pertaining to safety and effectiveness of products being developed; collate data obtained from various sources into comprehensive reports detailing findings; present results accurately & concisely to management team; provide feedback based upon analysis undertaken. Coordinate testing procedures carried out on finished goods prior to their release onto market; review test protocols carefully before they are executed; evaluate results obtained after completion of tests; determine whether or not products meet all criteria specified under applicable law/ regulation. Provide guidance to other departments within organization on matters relating to regulatory affairs; offer advice whenever requested by colleagues who may require assistance understanding complex rules governing medical device industry. Required Skills / Experience
Minimum 5 years’ experience working within regulatory affairs environment preferably focused on medical devices industry. Experience MUST be within a REGULATED Industry (examples; Medical Device, Aerospace, Automotive, Pharmaceutical). Strong analytical skills coupled with ability to think critically & solve problems independently. Excellent interpersonal skills with proven track record of building effective relationships internally & externally. Ability to communicate clearly & concisely both verbally & written form. Proven ability to manage multiple projects simultaneously while meeting tight deadlines. Proficiency in Microsoft Office Suite required (Word, Excel, PowerPoint). Preferred Skills / Experience
Bachelor’s degree in Science, Engineering, Pharmacy or equivalent field preferred but not essential provided candidate possesses sufficient relevant experience. Medical Device Industry preferred – will consider other REGULATED Industry experience. BILINGUAL Chinese/Mandarin would be beneficial but not essential. Why Join Us?
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Equal Opportunity Employer Statement
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
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Senior Regulatory Affairs Specialist – San Milpitas, CA Job Description Summary
BD Life Sciences is recruiting for a Senior Regulatory Affairs Specialist in San Milpitas, CA. The Sr. Regulatory Affairs Specialist will be responsible for the preparation and approval of regulatory submissions required to market new or modified in vitro diagnostic devices as well as research use only (RUO) products in global markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. It also requires identifying required documentation, management of submission to worldwide RA partners and working with cross functional teams to ensure that all data and information required for regulatory submissions and approvals are generated. Responsibilities
Manage the regulatory process by interacting directly with country RA partners and government agencies; provide updates on status of applications submitted to appropriate internal stakeholders; coordinate meetings between relevant departments when necessary; oversee submission package preparation including compilation of documentation required under applicable law or regulation; review draft documents prepared by others prior to submission; prepare correspondence regarding outcomes of submissions; respond promptly to queries received during evaluation period; liaise effectively between internal departments & external authorities throughout entire lifecycle of application until final decision has been made; participate actively in negotiations where required; contribute meaningfully towards resolution of any issues raised by authorities during evaluation phase so that timely decisions can be reached without unduly delaying progress toward ultimate goal – successful commercialization of products within targeted markets globally. Collaborate closely with internal functions such as Marketing, Sales, Technical Support etc., to understand customer needs better; identify potential areas where improvements could be made to enhance overall performance of existing products; develop strategies aimed at maximizing opportunities for growth through innovative solutions designed specifically around those requirements; leverage expertise gained via experience working across multiple disciplines to drive forward initiatives which benefit both organization and customers alike. Monitor changes in legislation relating to medical device industry; stay abreast of emerging trends affecting regulatory landscape globally; keep up-to-date records of key events occurring within sector; identify implications arising from new policies implemented by governments; assess impact on current operations; devise plans accordingly so as to not disrupt normal functioning of business units. Conduct regular audits to ensure compliance with relevant regulations governing medical devices; identify gaps if any exist between actual practices employed by organization versus standards set forth by authorities; implement corrective measures swiftly whenever deficiencies are detected. Work collaboratively with internal stakeholders such as R&D, Quality Control, Manufacturing etc., to gather information pertaining to safety and effectiveness of products being developed; collate data obtained from various sources into comprehensive reports detailing findings; present results accurately & concisely to management team; provide feedback based upon analysis undertaken. Coordinate testing procedures carried out on finished goods prior to their release onto market; review test protocols carefully before they are executed; evaluate results obtained after completion of tests; determine whether or not products meet all criteria specified under applicable law/ regulation. Provide guidance to other departments within organization on matters relating to regulatory affairs; offer advice whenever requested by colleagues who may require assistance understanding complex rules governing medical device industry. Required Skills / Experience
Minimum 5 years’ experience working within regulatory affairs environment preferably focused on medical devices industry. Experience MUST be within a REGULATED Industry (examples; Medical Device, Aerospace, Automotive, Pharmaceutical). Strong analytical skills coupled with ability to think critically & solve problems independently. Excellent interpersonal skills with proven track record of building effective relationships internally & externally. Ability to communicate clearly & concisely both verbally & written form. Proven ability to manage multiple projects simultaneously while meeting tight deadlines. Proficiency in Microsoft Office Suite required (Word, Excel, PowerPoint). Preferred Skills / Experience
Bachelor’s degree in Science, Engineering, Pharmacy or equivalent field preferred but not essential provided candidate possesses sufficient relevant experience. Medical Device Industry preferred – will consider other REGULATED Industry experience. BILINGUAL Chinese/Mandarin would be beneficial but not essential. Why Join Us?
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Equal Opportunity Employer Statement
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
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