Medical Device/Pharma client is looking for a Regulatory Affairs Manager to strengthen and help lead their QA/Regulatory team as part of their long-term strategic growth/succession planning. The ideal person possesses a strong sense of team, a go-getter attitude, a bright mind, and an open disposition.
The Regulatory/QA team works very closely together and is highly collaborative, the ideal person has directly managed a team, coached and has been responsible for the success of others, conducted performance reviews and directed day-to-day work for at least 5 years.
Location: This is an in-person role, 5 days per week, likely to be fully functioning after about a year of training. After 'fully trained', there may be an option to work remotely one day a week.
Local to Orange County, CA is preferred, relocation for the right candidate is possible.
Direct Reports: Will have 2 or 3 direct reports
location: Valencia, California
job type: Permanent
salary: $100,000 - 160,000 per year
work hours: 8 to 4
education: Bachelors
responsibilities:
- Operates under the guidance of the Director of Quality Operations to ensure compliance with the company's Quality System and Regulatory Affairs program.
- Keeps the Director of Quality Operations informed through reports, memos, and meetings.
- Serves as backup to the Director of Quality Operations.
- Acts as the Calibration Laboratory Management Representative.
- Maintains a compliant Quality Management System in accordance with:
- ISO 9001
- MDSAP (ISO 13485, TG(MD)R Sch3, RDC ANVISA 665/2022, CMDR, Japan MHLW Ministerial Ordinance No. 169, FDA 21 CFR 820)
- FDB, CA-RHB (product registrations, compliance, & licensing)
- NRC, BIS, DOT 49 CFR / IAEA
- DAkkS / ISO 17025
- MDD (93/42/EEC) and MDR (EU 2017/745) CE Mark
- Maintains CA-RHB product registrations and licensing.
- Conducts annual cGMP training and new employee training as required.
- Maintains additional regulatory systems and ensures compliance.
- Revises outdated procedures to maintain product quality assurance and control.
- Organizes and leads group and individual seminars on the Quality & Regulatory System.
- Leads internal audits, issues CAPAs, and ensures timely closure and evaluation of corrective actions.
- Prepares and maintains internal audit reports and historical records.
- Trains internal auditors.
- Schedules and conducts supplier audits and maintains associated QA/QC manuals and historical files.
- Manages the approved supplier program and provides supplier audit reports to the Director of Quality Operations.
- Oversees company's Regulatory Affairs program.
- Conducts regulatory reviews (SS&DRs, CMDR licenses, RMLs, MDD / MDR, export control).
- Reviews customer licenses and interacts with regulatory agencies and customers as necessary.
- Applies for export licenses from BIS and NRC.
- Serves as backup to the Regulatory Affairs Officer.
- Maintains sealed source and device registries, including submissions, amendments, and transfers.
- Maintains Special Form Radioactive Materials compliance.
- Creates and approves capsule/package test documentation and certificates.
- Maintains Health Canada establishment registration and device license renewals.
- Maintains technical files for CE Mark compliance (MDD/MDR).
- Prepares international registration documentation for product sales.
- Supports the Document Management Program.
- Approves all controlled procedures, engineering drawings, and Engineering Change Orders.
- Manages documentation control activities.
- Leads the Customer Complaints and Returns program:
- Evaluates customer complaints with Sales input
- Final approval of Complaints and Returns reports
- Supports audit scheduling, participation, follow-up, and leadership.
- Conducts Quality and Regulatory training sessions.
- Participates in interviewing employment candidates and recommends hires to management.
- Assigns and directs work, sets department goals, and evaluates performance.
- Provides training, motivation, and corrective action as needed.
- Travels to Burbank, Valencia, and other locations for supplier audits and training.
- Performs other duties as assigned by management.
qualifications:
- Minimum 5 years of experience as a manager in Regulatory Affairs.
- Proven track record of successful regulatory submissions.
- Strong interpersonal skills, with the ability to communicate effectively at all levels of the organization.
- Excellent problem solving, prioritizing, and time management skills.
skills: FDA Submissions, Medical Device Regulation (MDR)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
