- Coordinates and prepares (i.e., plans, writes, and reviews) timely submissions, including interfacing with other departments to obtain the necessary components and reports in accordance with regulatory agencies' guidelines.
- Reviews submission-related documents from clinical, pre-clinical, research, development and manufacturing to ensure consistency with regulatory submissions and compliance with applicable regulations.
- Keeps abreast of current EU MDR, MDCG and international regulatory practices and guidance's, procedures and changes, as appropriate by project. Assesses impact of the changing regulatory environment to the project, and advises regulatory colleagues and project team members, as appropriate, regarding potential course(s) of action.
- Participates in and/or represents Regulatory Affairs on project teams.
- Maintains regulatory filings or records, including archive of submissions and correspondences files.
- Actively participates in the development of regulatory strategies in conjunction with senior RA personnel.
- Assists with publishing or compilation of EU/EMEA, LATAM and APAC submissions and renewals.
- Completes regulatory assessments and submissions for change controls
- Completes reporting assessments for Product Complaints and Adverse Events
- Regularly interacts with management regarding regulatory matters
- Perform other related duties as required
- Bachelor's degree or equivalent with 5 years experience in Regulatory Affairs in a biotechnology, pharmaceutical, or medical device company.
- Must be able to work in a fast-paced environment with demonstrated ability to effectively manage multiple competing tasks and demands.
- Ability to drive projects to completion within deadlines.
- Ability to negotiate and influence others.
- Strong problem-solving skills.
- Ability to manage projects.
- Strong communication skills (interpersonal, written, verbal, listening).
- Demonstrated time management (timelines, schedules, task prioritization).
- Detail and accuracy oriented.
- Language preference: English (mandatory), Spanish (preferred)
Regulatory Affairs Manager - Concord, United States - Cerus Corporation
Description
About Cerus:
Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world.
This is a fully remote opportunity.
Summary & Scope of Position:
Manage assigned regulatory projects and/or submissions ensuring that Company products comply and meet national and international regulatory requirements and standards.
Primary Responsibilities:
Qualifications/Requirements/Skills:
We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees' lives both on and off the job.
Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), ESPP, RSUs
Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement
Compensation: The base salary range for this position in the San Francisco bay area is $130,651-$173,251 annually.Compensation may vary outside of this range depending on various factors, including a candidate's qualifications, skills, competencies, experience, and location. Base pay is one part of the total package to compensate and recognize employees for their work.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.