Senior Manager, Regulatory Affairs & Compliance

At Pacira, innovation meets purpose.

Pacira BioSciences, 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.

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.

1. 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.
2. Maintain and update regulatory SOPs and work instructions, ensuring alignment with current regulations, standards and guidance changes.
3. 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.
4. Execute regulatory strategy to enable timely development, registration, and commercialization of medical devices across the product lifecycle.
5. Participate and provide regulatory guidance and expertise to cross-functional teams, including R&D, Quality Assurance, and Marketing, throughout the product lifecycle.
6. Assess and interpret regulatory requirements and provide recommendations on product development plans, labeling, human factors studies, and clinical trial designs to ensure compliance.
7. 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
8. Establish and maintain Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities and reports in compliance with global regulatory requirements
9. Ensure compliance of labeling and promotional materials with approved claims and regulatory requirements.
10. Establish and maintain relationships with key stakeholders, industry organizations, and trade associations to stay informed about regulatory changes and best practices.
11. Train and mentor teams on regulatory requirements, procedures, and best practices to strengthen compliance execution.
12. 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.

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 leadership and communication skills, with the ability to collaborate effectively with cross-functional teams and influence key stakeholders

• Experience with product development processes and design controls
• Proficient with Microsoft Office tools (including Word, Excel, PowerPoint)
• Ability to develop and track a variety of diverse project budgets and identify key performance indicators in a fast-paced, changing environment

• Ability to present scientific and technical information in a concise and clear manner

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse. Will need to lift and move items weighing up to 20 pounds.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The work setting is consistent of a typical pharmaceutical office environment with offices and cubicles.

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program
• Mental Health Resources
• Disability Coverage
• Life insurance
• Critical Illness and Accident Insurance
• Legal and Identity Theft Protection
• Pet Insurance
• Fertility and Maternity Assistance
• 401(k) with company match
• Flexible Time Off (FTO) and 11 paid holidays
• Paid Parental Leave

The base pay range for this role is $120,000 to $165,000 per year.

The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered.

EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.