Junior Regulatory Affairs Specialist

Pro-Dex, Inc.; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Pro-Dex, Inc. in Irvine, CA is seeking a Regulatory and Compliance Specialist to support product development with regulatory inputs, strategies, and design control deliverables. The role ensures compliance with local, state, federal and international requirements for medical devices.

Responsibilities include preparing submissions, reports, and supporting audits, while maintaining procedures and supporting 510(k)/CE documentation. Travel is occasional; in-office position in Irvine.

Qualifications

• Knowledge of 21 CFR QSR/cGMPs and ISO 13485 required.
• Experience with MDSAP and EU/UK medical device regulations a plus.
• Proficiency in scientific technical writing.

Responsibilities

• Support Product development teams to deliver regulatory inputs, strategies, reports and other design control deliverables.
• Prepare QA/Regulatory reports and present status in review meetings.
• Prepare reports and documents necessary for Regulatory Agency submissions or in support of customer QARA needs.
• Perform research to determine Regulatory requirements of product markets.
• Support internal, agency and customer audits and any resulting nonconformity / improvement actions.
• Prepare and support deliverables for 510K and CE Marking submission documents and maintain records.
• Maintain current procedures and assist with changes to meet new regulatory requirements.

Skills

Regulatory affairs

cGMP knowledge

ISO 13485

MDSAP

Scientific writing

MS Word

Excel

Access

ERP systems

Analytical thinking

Communication skills

Regulatory strategy

Education

Bachelor of Science

Tools

MS Word

Excel

Access

ERP systems

Job description

Please note this is an in-office position, requiring candidates to be in Irvine, CA. Relocation is not provided for this position.

Highly applicable candidates for this role will have a background or degree in science and strong communication skills.

JOB SUMMARY

Supports tasks related to Regulatory and Compliance activities including tasks to ensure compliance during product development activities, local, state, federal and any outside US requirements. Supports activities to ensure products consistently meet or exceed established compliance and quality standards. Ensure that processes and work practices are compliant to applicable local, state, federal, international regulations and customer requirements pertaining to medical device and medical device manufacturing, worker health and safety, and environmental protection. Support/execute planned facility and product development RA strategies. Responsibilities include support for QA/RA related operational activities within the Quality System that may include processes such as recall investigations/activities, Audits, Deviations and Process/Product Validations and Product Development/Design Control deliverables.

JOB DUTIES

• Support Product development teams to deliver regulatory inputs, strategies, reports and other design control deliverables.
• Prepare Quality Assurance/Regulatory reports and present status in review meetings.
• Prepare reports and documents necessary for Regulatory Agency submissions or in support of customer QARA needs.
• Perform research to determine Regulatory requirements of product markets & product requirements
• Support internal, agency and customer audits and any resulting nonconformity / improvement actions.
• Support safety inspection findings.
• Support recurring and new product and facility licenses, listings, technical files, submissions.
• Maintain and support material controls and deliverables to meet requirements of RoHS, REACH, Conflict Minerals, Prop 65, and other applicable material controls.
• Support/fulfill requirements related to CAFDB, USFDA, EU MDR, UK MDR, Health Canada, OSHA, DTSC, OC Health, and other regulating agencies.
• Maintain current procedures.
• Prepare and support deliverables for 510K and CE Marking submission documents and maintain records.
• Assess/notify management of changes or new regulatory requirements; collaborate on their application within the QMS, product markets, or products
• Prepare a variety of written correspondence and documents.
• Perform other duties as assigned.

SKILLS AND QUALIFICATIONS

Must be competent with requirements of 21 CFR Quality System Regulations/cGMPs and ISO 13485 Quality System Standard. Knowledge and experience with Medical Device Single Audit Program (MDSAP) and EU/UK medical device regulations a plus. Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to research, write and support regulatory strategies and supporting documentation/reports. Ability to analyze trends and draw logical conclusions. Must be proficient in scientific technical writing. Must be proficient in Microsoft Word/word processing and Excel/spreadsheet as essential skills. Proficiency in Access and ERP systems a plus. Critical thinking, facilitation, negotiation skills and collaboration abilities essential.

ACCOUNTABILITIES

• Provide deliverables for Regulatory and Safety compliance including reports. Must provide accurate and complete deliverables on time.
• Self starter and can research internal, customer and regulatory requirements without prompt to ensure deliverables are on time, accurate and meets requirements.
• Ascertain integrity of procedures.
• Ensure that work is being performed in accordance with documented procedures.
• Seek to improve and make changes in procedures to document “best practices”.
• Keep up with all regulations and stay informed of organizational changes.
• Remain well prepared for audits by external agencies/organizations (including, but not limited to FDA, ISO, EPA, OSHA).
• Sustain safe work environment.

EDUCATION AND EXPERIENCE

Bachelor of Science. Experience preferred in in Quality Control, Quality Assurance or regulatory affairs. One or more years of experience in Quality with medical device manufacturing background. Must have experience working with ISO Quality System Standard and Quality System Regulations. Must have background working regulated environment. Experience in industrial hygiene/safety, government regulations, EU MDR, ISO, MDSAP, operational auditing, work flow analysis, technical writing, and manufacturing operations preferred.

Quality Assurance/Regulatory Affairs Specialist

MENTAL, PHYSICAL AND VISUAL DEMANDS

Position entails some travel. Ability to work under pressure of deadlines is necessary. Physical demands include working with hands and visual demands entail close vision.

We are an Equal Employment Opportunity (“EEO”) Employer.

We are an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. The Company makes hiring decisions based solely on qualifications, merit, and business needs at the time