Regulatory Affairs Specialist 3 - Medical Device IVD
Grifols, San Diego, TX, United States
Overview
Grifols Diagnostic Solutions in San Diego, CA is seeking a Regulatory Affairs Specialist III. The role is responsible for ensuring regulatory compliance and supporting global market access for in vitro diagnostic (IVD) products.
The position involves developing and executing regulatory strategies, preparing and submitting complex pre‑market and post‑market applications to the FDA, EU Notified Bodies, and other international authorities, and managing communications with health agencies. It requires collaboration with cross‑functional teams, providing regulatory input throughout the product lifecycle, mentoring junior colleagues, and proactively monitoring evolving regulations to identify risks and implement mitigation plans. Strong technical expertise, analytical skills, and the ability to influence stakeholders are essential.
Primary Responsibilities
Prepare and file complex pre‑market and post‑market regulatory submissions with the US FDA, EU Notified Bodies, and other international regulatory bodies.
Track submissions, correspondence, and commitments with health authorities, and prepare timely responses and comments.
Develop and execute submission strategies, guide cross‑functional product teams, and monitor project progress.
Collaborate with subject matter experts to ensure regulatory requirements are met and technical data are incorporated.
Execute projects independently to align with and achieve management goals and timelines.
Make decisions and influence stakeholders based on regulatory knowledge and current compliance trends.
Communicate complex regulatory topics to cross‑functional management and adapt the communication style to the audience.
Proactively research applicable regulations, assess impacts, lead mitigation projects, and reduce regulatory risk.
Review and provide regulatory input to quality management system documents, including validations and complex reports.
Support lower‑level regulatory team members through mentoring and training.
Assess regulatory impact of product changes and incorporate assessments into change control systems.
Prepare documentation to support regulatory inspections and auditor requests.
Identify and drive process‑improvement initiatives.
Provide regular status updates on projects to management.
Perform additional duties as assigned.
Knowledge, Skills, and Abilities
Commitment to excellence and ability to work in a fast‑paced, technical team setting.
Independent coordination and management of complex projects, prioritizing multiple responsibilities.
Balance independent work with team interaction, being a cross‑functional team player.
Strong interpersonal skills, experience influencing people, and building positive relationships.
Ability to identify issues, assess urgency, and provide solutions.
Understanding of IVD regulations and advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components.
Excellent oral, written, and presentation skills for complex concepts.
Technical writing skills with ability to translate scientific information into submission documents.
Expert attention to detail and identification of inconsistencies in documentation.
Analytical and problem‑solving skills to determine root cause and provide solutions.
Experience communicating with FDA and international customers (regulatory agencies, business partners).
Proficient in Microsoft Office, Adobe, and Excel.
Knowledge of document management control systems (eg. LSQM), change control systems (eg. SAP), and JIRA.
Education
Bachelor’s degree in life sciences, engineering, or a related field.
Experience
Six years in a regulated environment with four years of direct regulatory affairs experience. Prior experience in the IVD or drug/biologics industry is required.
Equivalency
Eligible if the candidate has an alternative combination of education and experience that meets the required total of experience, such as eight years of experience, an associate’s degree with six years of experience, or a master’s degree with two years of experience.
Occupational Demands
Office environment with exposure to electrical office equipment. Requires sitting for 6–8 hours per day, frequent hand movements, occasional walking, bending, and twisting of the neck. Light to moderate lifting of up to 25 lbs. Ability to communicate complex information, work independently, and interact with diverse groups.
Pay Scale
Estimated pay range: $105,800 to $132,250 per year. Eligibility for participation in up to 8% of the company bonus pool. Additional benefits include medical, dental, vision, PTO, up to 5% 401(k) match, and tuition reimbursement.
Equal Employment Opportunity Statement
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices, national origin, pregnancy, childbirth, related medical conditions, status as a protected veteran or spouse/family member of a protected veteran, or disability. The company will consider all qualified applicants in a manner consistent with applicable laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance, and the City of Los Angeles Fair Chance Initiative for Hiring Ordinance.
Location
San Diego, CA – Willow Ct Mfg.
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Grifols Diagnostic Solutions in San Diego, CA is seeking a Regulatory Affairs Specialist III. The role is responsible for ensuring regulatory compliance and supporting global market access for in vitro diagnostic (IVD) products.
The position involves developing and executing regulatory strategies, preparing and submitting complex pre‑market and post‑market applications to the FDA, EU Notified Bodies, and other international authorities, and managing communications with health agencies. It requires collaboration with cross‑functional teams, providing regulatory input throughout the product lifecycle, mentoring junior colleagues, and proactively monitoring evolving regulations to identify risks and implement mitigation plans. Strong technical expertise, analytical skills, and the ability to influence stakeholders are essential.
Primary Responsibilities
Prepare and file complex pre‑market and post‑market regulatory submissions with the US FDA, EU Notified Bodies, and other international regulatory bodies.
Track submissions, correspondence, and commitments with health authorities, and prepare timely responses and comments.
Develop and execute submission strategies, guide cross‑functional product teams, and monitor project progress.
Collaborate with subject matter experts to ensure regulatory requirements are met and technical data are incorporated.
Execute projects independently to align with and achieve management goals and timelines.
Make decisions and influence stakeholders based on regulatory knowledge and current compliance trends.
Communicate complex regulatory topics to cross‑functional management and adapt the communication style to the audience.
Proactively research applicable regulations, assess impacts, lead mitigation projects, and reduce regulatory risk.
Review and provide regulatory input to quality management system documents, including validations and complex reports.
Support lower‑level regulatory team members through mentoring and training.
Assess regulatory impact of product changes and incorporate assessments into change control systems.
Prepare documentation to support regulatory inspections and auditor requests.
Identify and drive process‑improvement initiatives.
Provide regular status updates on projects to management.
Perform additional duties as assigned.
Knowledge, Skills, and Abilities
Commitment to excellence and ability to work in a fast‑paced, technical team setting.
Independent coordination and management of complex projects, prioritizing multiple responsibilities.
Balance independent work with team interaction, being a cross‑functional team player.
Strong interpersonal skills, experience influencing people, and building positive relationships.
Ability to identify issues, assess urgency, and provide solutions.
Understanding of IVD regulations and advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components.
Excellent oral, written, and presentation skills for complex concepts.
Technical writing skills with ability to translate scientific information into submission documents.
Expert attention to detail and identification of inconsistencies in documentation.
Analytical and problem‑solving skills to determine root cause and provide solutions.
Experience communicating with FDA and international customers (regulatory agencies, business partners).
Proficient in Microsoft Office, Adobe, and Excel.
Knowledge of document management control systems (eg. LSQM), change control systems (eg. SAP), and JIRA.
Education
Bachelor’s degree in life sciences, engineering, or a related field.
Experience
Six years in a regulated environment with four years of direct regulatory affairs experience. Prior experience in the IVD or drug/biologics industry is required.
Equivalency
Eligible if the candidate has an alternative combination of education and experience that meets the required total of experience, such as eight years of experience, an associate’s degree with six years of experience, or a master’s degree with two years of experience.
Occupational Demands
Office environment with exposure to electrical office equipment. Requires sitting for 6–8 hours per day, frequent hand movements, occasional walking, bending, and twisting of the neck. Light to moderate lifting of up to 25 lbs. Ability to communicate complex information, work independently, and interact with diverse groups.
Pay Scale
Estimated pay range: $105,800 to $132,250 per year. Eligibility for participation in up to 8% of the company bonus pool. Additional benefits include medical, dental, vision, PTO, up to 5% 401(k) match, and tuition reimbursement.
Equal Employment Opportunity Statement
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices, national origin, pregnancy, childbirth, related medical conditions, status as a protected veteran or spouse/family member of a protected veteran, or disability. The company will consider all qualified applicants in a manner consistent with applicable laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance, and the City of Los Angeles Fair Chance Initiative for Hiring Ordinance.
Location
San Diego, CA – Willow Ct Mfg.
#J-18808-Ljbffr