Senior Regulatory Affairs Specialist - Palo Alto, United States - Planet Pharma
Description
onsite Palo Alto, CA
Summary:
The Staff/Principal Regulatory Affairs Specialist will be part of a high-performing RA team and responsible for contributing to the development of regulatory strategies, preparing U.S. and major market submissions and obtaining approval for the product portfolio.
Responsibilities and Duties:
Manages post market activities, including but not limited to EU MDR and MEDDEV compliant Clinical Evaluation documents for new products and maintain/update existing company Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post Market Clinical Follow Up (PMCF) Plans/Reports, Periodic Safety Update Reports, Post approval study reports in alignment with applicable clinical and regulatory standards and business needs.
Represent regulatory in clinical program teams and communicate regulatory strategies.
Review and approve internal engineering documentation and change orders.
Provide support to currently marketed products as necessary including review of labeling, promotional material, product changes and documentation for changes.
Lead product related regulatory compliance activities, including WEEE, Prop 65, REACH and RoHS.
Develops and implements processes involved with maintaining annual licenses, registrations and listings. Ensures both regulatory compliance needs, and business needs are met.
Lead the development of internal procedures, templates, style guides and departmental continuous improvement initiatives as they relate to the function.
Interprets new or existing regulatory requirements (US, EU, OUS) as they relate to the product portfolio and regulatory and quality system procedures.
Complies with U.S. Food and Drug Administration (FDA), EU and international regulations, other regulatory requirements, company policies, and governing procedures and processes.
Keep abreast of changes in agency regulations and requirements, and trains stakeholders accordingly.
Assist in organizational and planning skills to manage complex regulatory projects within timelines and budgets.
Provide business and product information to international regulatory staff to enable development of strategies and requirements for global commercialization.
Continuously evaluate, recommend, and implement improvements as needed.
Willingness to perform other responsibilities as assigned.
Requirements:
Minimum of a Bachelors degree preferably in life sciences and/or biomedical engineering. Advanced degree preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
Minimum of 7 years experience in regulatory within medical device industry and 5 years with CEP, CER, PMCF.
Prior experience with US IDE submissions, CER, PMS, PMCF
Experience/knowledge of MDR requirements and Clinical evaluation requirements.
Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
Experience with medical device hardware and software requirements and software regulations.
Demonstrated ability to work well in dynamic and cross functional team environment.
Demonstrated collaboration and leadership skills in team setting.
Solid understanding of design control and change control.
Experience reviewing design specifications and other technical documents.
Excellent interpersonal and communication skills, both oral and written.
Ability to identify risk areas and escalate issues as appropriate.
Self-motivated with excellent time management skills
Strong team player; willing to work collaboratively.
pay within this range will be commensurate with level of experience
604900