Senior Regulatory Affairs Specialist

3+ years

$120,000 - $130,000 annually

Pacheco

10 Oct. 1, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Our Company

Biocare Medical, LLC is a leader in developing and supplying state-of-the-art automated immunohistochemistry instrumentation and a comprehensive range of reagents for immunohistochemistry and molecular lab testing. As the market leader in simultaneous multiplex IHC tests, we enhance diagnostic confidence at critical decision points, positively impacting patient therapy and accelerating turnaround times.

Our clientele includes clinical histology laboratories, pharmaceutical companies, contract research organizations (CROs), biotechnology firms, as well as academic, government, military, and nonprofit laboratories. Biocare Medical boasts a growing portfolio of integrated products designed to address the rapidly expanding markets for cancer and infectious disease diagnostics, utilizing innovative tissue immunohistochemistry and in situ hybridization methods. Headquartered in California, we operate manufacturing facilities and maintain a global distribution network.

Summary

This onsite position is responsible for ensuring product compliance and monitoring the company’s adherence to relevant regulatory requirements. You will support product development and facilitate global regulatory submissions related to product marketing. Staying current with applicable regulations and harmonized standards is essential.

Essential Functions

(Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.)

Ensure the company maintains compliance with regulatory requirements and established quality system standards.
Participate in internal and external audits and inspections, including necessary follow-up activities.
Contribute to the risk management process, including product risk assessments and benefits analysis throughout the product lifecycle.
Manage recall, Medical Device Reporting (MDR), and advisory notice activities to ensure appropriate monitoring and reporting as per established procedures.
Provide regulatory guidance to departments or development project teams on design, development, change control, testing, labeling, and marketing of products.
Maintain registration and product listing/licensing with regulatory agencies and support renewal of necessary business licenses, including documentation for authorized representatives and distributors.
Review and approve product labeling, including labels, data sheets, user manuals, safety data sheets, and promotional materials.
Conduct company-wide compliance training as needed.
Generate Technical Documentation, including regulatory plans, clinical evaluations, and post-market reports.
Support and participate in Corrective and Preventive Actions (CAPAs) as required.
Stay updated on regulatory legislation changes that may impact the company and conduct gap analyses as necessary.
Develop and review Standard Operating Procedures (SOPs) to ensure regulatory compliance.
Complete and support regulatory submissions (e.g., 510(k)) and product registrations according to established strategies.
Maintain required documentation, such as Certificates to Foreign Government (CFG).
Facilitate customs clearance, including generating necessary documentation.
Perform other duties as assigned by management.

Competencies

BS/BA degree with five (5) years of experience in the pharmaceutical or medical device industry, or MS degree with three (3) years of relevant experience.
Strong oral and written communication skills.
Ability to set and drive aggressive project timelines.
Strategic thinking skills with the ability to propose solutions to regulatory challenges.
Attention to detail and strong organizational abilities.
Problem-solving and investigative skills.
High reading comprehension level.
Independent judgment within broadly defined policies and ability to manage multiple projects.
Strong computer skills and internet research literacy.
Knowledge of FDA/EMEA regulations and ISO/GMP standards.

Location & Hours of Work

Location: Onsite - Pacheco, CA
Hours: 8 a.m. to 5 p.m., Monday – Friday. This position may require extended weekday or weekend hours based on business needs.

Compensation Range

Salary: $120,000 - $130,000 annually

Full-Time Position Offers

Company-sponsored health insurance (medical, dental, vision)
Company-sponsored life insurance
Voluntary benefits
Retirement plan (401k)
Paid time off (PTO)
Paid holidays

Biocare Medical values the diversity of individuals, ideas, and perspectives and recognizes the significant contributions they bring to our workplace. We are committed to hiring the best talent from around the world and ensure that all qualified candidates receive equal consideration for employment, regardless of race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, physical or mental disability, or veteran status.

All inquiries are strictly confidential.

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