Senior Manager,Regulatory Affairs & Compliance Job San Diego area,California USA,Healthcare

Overview

At Pacira, innovation meets purpose.

Pacira Bio Sciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. Today, we're building on that legacy with next-generation innovations for chronic, postsurgical, and musculoskeletal pain. Our culture is built on collaboration, innovation, and a shared commitment to helping patients recover faster. We are redefining what's possible in pain management—and we can't do it without talented people like you.

Why

Join Us?

At Pacira, every career is more than a job. Our mission drives us, and every day, we challenge ourselves to achieve the extraordinary. Integrity is at the core of who we are. We value diverse perspectives and the collective strength of a unified team. Join the team in making better possible for patients everywhere.

Summary

This role will work hands-on with cross-functional teams to develop and execute regulatory strategies that support business objectives while ensuring full compliance with applicable regulations and standards, including compliance with US FDA regulations governing the distribution and sale of medical devices domestically and internationally. The role also serves as the primary liaison with regulatory authorities, ensuring labeling, marketing materials, and post-market activities meet domestic and international regulatory requirements.

Responsibilities

Essential Duties and Responsibilities

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

Author, prepare and submit U.S. and global regulatory filings, including Traditional and Special 510(k) s, Letters to File, Pre-Subs, IDEs, technical documentation for European Union, and related submissions.

Maintain and update regulatory SOPs and work instructions, ensuring alignment with current regulations, standards and guidance changes.

Monitor and manage surveillance of evolving regulations, standards and guidance, and drive implementation required changes impacting product design, safety, regulatory compliance, post-market activities, and QMS processes.

Execute regulatory strategy to enable timely development, registration, and commercialization of medical devices across the product lifecycle.

Participate and provide regulatory guidance and expertise to cross-functional teams, including R&D, Quality Assurance, and Marketing, throughout the product lifecycle.

Assess and interpret regulatory requirements and provide recommendations on product development plans, labeling, human factors studies, and clinical trial designs to ensure compliance.

Manage and maintain regulatory documentation, product registrations, and regulatory correspondence while serving as the primary liaison with regulatory authorities including FDA, notified bodies, and other agencies to drive product approvals, clearances, and registrations.

Establish and maintain Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities and reports in compliance with global regulatory requirements.

Ensure compliance of labeling and promotional materials with approved claims and regulatory requirements.

Establish and maintain relationships with key stakeholders, industry organizations, and trade associations to stay informed about regulatory changes and best practices.

Train and mentor teams on regulatory requirements, procedures, and best practices to strengthen compliance execution.

Perform additional regulatory and compliance activities as assigned or at management's discretion, supporting organizational priorities and ensuring ongoing adherence to global regulations and QMS standards.

Supervisory Responsibilities

This position may have supervisory responsibilities.

Interaction

This position works closely with R&D, Quality, Manufacturing, Marketing, and other cross functional leaders, as well as external vendors and regulatory consultants.

Qualifications

Education and Experience

Bachelor's degree in a relevant discipline required
Minimum of 8 years of regulatory affairs experience in the medical device industry required
International regulatory experience required
Regulatory Affairs Certification (RAC) preferred

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Knowledge,

Skills and Abilities

In-depth knowledge of medical device regulations and standards, such as FDA regulations (21 CFR Part 820) and ISO 13485
Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions
Experience interacting with regulatory agencies, such as the FDA and notified bodies
Excellent project management skills, with the ability to prioritize and manage multiple projects simultaneously
Strong…


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Senior Manager, Regulatory Affairs & Compliance