Regulatory Affairs Specialist 3 - Medical Device IVD

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Grifols Diagnostic Solutions in San Diego, CA is seeking a Regulatory Affairs Specialist III. The Regulatory Affairs Specialist III is responsible for ensuring regulatory compliance and supporting global market access for in vitro diagnostic (IVD) products. It involves developing and executing regulatory strategies, preparing and submitting complex pre-market and post-market applications to FDA, EU Notified Bodies, and other international authorities, and managing communications with health agencies. This role 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 for success in this position.

To qualify for the Regulatory Affairs Specialist III role, candidates must have a Bachelor's degree in life sciences, engineering, or a related field, along with at least 6 years of experience in a regulated environment, including 4 years of direct experience in Regulatory Affairs. Prior experience in the IVD or Drug/Biologics industry is required.

Primary responsibilities for role:

• Prepares and files complex pre-market and post-market regulatory submissions with the US FDA, Notified Bodies in the EU and other international regulatory bodies, as applicable. Prepares clear, complete, and accurate documents that are logically constructed and comprehensive in content according to established templates and timelines.
• Tracks submissions, correspondence, and commitments with health authorities and prepares responses and comments from regulatory agencies independently, proactively, in compliance with regulatory guidelines/requirements and according to established timelines. Communicates with Health Authorities and has a demonstrated ability to facilitate requests and anticipate appropriate next steps.
• Develop and execute submission strategies based on ability to understand complex technical information, and provide guidance to existing and new cross-functional product core teams for new product development and various on-market enhancements/changes from product concept to placing on the market. Monitor progress on key project deliverables and provide status updates to management on a regular basis.
• Collaborate with subject matter experts to ensure regulatory submissions requirements are being met and technical and scientific data are incorporated into regulatory submissions, and collaborate with partners and local liaisons for management of submissions in foreign countries and facilitate meetings with SMEs as needed to track progress.
• Execute projects without supervision to align with and achieve the goals and timelines set by management
• Makes decisions and influences stakeholders and teammates based on gained regulatory knowledge and experience, technical expertise and current regulatory compliance trends
• Communicates moderately complex to complex regulatory topics to cross functional management, modify their communication style to fit the audience by embracing cultural differences and recognizing different knowledge levels.
• Proactively research applicable regulations and guidance to the company's products and stay up to date on the current regulatory requirements and industry trends. Assess the impact of applicable regulations to the company's products and be able to identify mitigation plans, lead mitigation projects, and make decisions that will assist in reducing regulatory risk.
• Review, provide regulatory input to, and approve various quality management system related documents including utilizing scientific concepts to critically review complex reports, validations, etc. to ensure regulatory requirements are being adequately addressed.
• Provide support to lower level regulatory team members by sharing gained regulatory expertise, mentoring, reviewing submissions and/or training to company products and processes.
• Assess changes to product for regulatory impact and include regulatory assessments in the established change control systems, as applicable.
• Prepare regulatory documentation to support regulatory inspections/audits and to meet auditor/inspector requests
• Identify process improvement initiatives and drives their successful execution
• Provides regular status updates on projects to management.
• Additional duties assigned as needed.

Knowledge, Skills, and Abilities

• This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting.
• Demonstrated ability to independently coordinate and manage complex projects, prioritize multiple responsibilities and drive projects to completion
• Demonstrated ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team
• Demonstrated interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships
• Demonstrated ability to identify issues, understand their urgency, escalate to management, and provide solutions.
• Demonstrated understanding of IVD regulations, advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
• Strong oral and written communication and presentation skills, capable of presenting and explaining complicated concepts to colleagues within the organization
• Strong technical writing skills with ability to translate scientific information into technical documentation for submission to regulatory authorities
• Demonstrates expert attention to detail with ability to identify areas of improvement and possible inconsistencies in documentation
• Expert analytical and problem-solving skills, capable of identifying problems, determining root cause and providing solutions to management
• Demonstrated ability to communicate with FDA and international customers (e.g., regulatory agencies, business partners, etc.)
• Exceptional computer skills in Microsoft Office, Adobe, Excel
• Knowledge in document management control systems (e.g. LSQM), change control systems (e.g. SAP), JIRA, required

Education

Bachelor's Degree required in the life sciences, engineering or similarly related field

Experience

6 years of experience in a regulated environment with 4 years direct experience in Regulatory Affairs. IVD or Drug/Biologics Industry experience required.

Equivalency

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.

Occupational Demands

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

Pay Scale

The estimated pay scale for the Regulatory Affairs Specialist III role based in San Diego, CA, is $105,800 to $132,250 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

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Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.