Regulatory Affairs Project Manager
Company: New World Medical
Position: Talent Acquisition Partner
Location: Rancho Cucamonga
Posted: December 28, 2021
The Regulatory Affairs Project Manager will be responsible for providing strategy for new product approvals under the direction of the Sr. Global Regulatory Affairs Manager.
This position will be responsible for understanding regulations applicable to medical devices, investigating and evaluating regulatory history/background of class, disease/ therapeutic context in order to assess regulatory implications for approval, and determine trade issues to anticipate regulatory obstacles. Will help develop RA strategy for new products and changes to marked products and participate in new product development meetings, activities and support International and domestic registrations, such as Technical File, Design Dossier, 510k(k), IDE, and PMA. Participate in and provide input to project teams to assure that international product registrations and licensing applications (original submission and subsequent product enhancements) meet regulatory requirements. Maintain technical expertise through familiarity with the literature, attendance at professional meetings and participation in team meetings. Interpret new or existing regulatory requirements as they relate to ophthalmic medical products and procedures. Review and advise on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations. Comply with applicable corporate policies and procedures.
Additionally, the person in this role is responsible for assessment of device changes for regulatory implications and performing regulatory activities in support of implanting these device changes. Develops and maintains solid working relationships with other organizational functions (e.g. Quality, R&D, Marketing).
- Provide guidance and direction to ensure international product registration/licensing requirements are addressed and met prior to commercial release.
- Prepares documentation that is complete, accurate, and on time.
- Utilizing detailed, in-depth understanding of regulations, interprets regulations, and provides regulatory guidance to product development teams.
- Assist in the development of RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met.
- Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
- Participates in audits and inspections of the company and its quality systems.
- Represent Regulatory Affairs on assigned project teams through all phases of product development and communicate regulatory requirements.
- Review marketing materials, go-to-market strategies and other commercialization activities as required to ensure continued compliance to established product clearances; lead the development of regulatory strategies for new claims and indications.
- Support domestic and international field corrective actions and adverse event reporting.
- Create and update departmental standard operating procedures (SOPs).
- Perform all activities in compliance with the Quality System, ISO 13485, MDR, MHLW, CMDR, MDSAP and all other applicable are met.
- All other duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES:
- Direct experience with preparing for 510(k), IDE and Technical File and Design Dossier.
- Direct experience with preparing Pre-Submissions and interfacing with FDA personnel.
- Excellent knowledge and experience with global medical device regulatory requirements, design control and product registration.
- Working knowledge of product development process.
- Ability to assess the changes to marketed products and their impact on product registration.
- Ability to identify, research, and analyze technical documentation and governmental regulations
- Excellent oral and written communication skills.
- Experience working in cross-functional product development team.
- Must be able to efficiently handle multiple tasks/projects and manage priorities accordingly.
- Effective interpersonal/communication skills.
- Works well under pressure in a dynamic timeline-driven environment.
- Ability to work in a team environment, collaborate with Team members and exert influence without alienating others.
- Ability to work independently with minimal management oversight.
- Under general supervision, works within established guidelines and has flexibility as to method, priority and timing of job duties. This position requires a significant amount of initiative and judgment.
- Extensive experience with MS Word and EXCEL.
- Regulatory Affairs Certification (RAC) preferred.
EDUCATION AND EXPERIENCE:
The person responsible for regulatory compliance must possess the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:
- Master’s Degree in biology, chemistry, scientific or engineering discipline;
- 8+ years of work experience in regulatory affairs in medical device, biotech, or pharmaceutical industry
- Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for medical devices (510(k), IDE, PMA, Technical File, Design Dossier).
- Must be able to remain in a stationary position at least 50% of the time.
- Must be able to travel to the office on occasion, if working remotely. Additional travel may include travel to trainings and surgery sites.
- Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
- Ability to listen and speak with others. Must be able to exchange accurate information in these situations.
- View and type on computer screens for long periods of time.
This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.