Senior Regulatory Affairs
900 Island Dr, Suite 101 Redwood City, CA 94065 | Direct Hire
Bayside Solutions is seeking a Senior Regulatory Affairs Specialist to be part of our Client’ s team on the Peninsula. This is an opportunity to work with a local Biotechnical company focusing on the discovery, development, manufacturing and commercialization of medicines to treat patients with serious or life-threatening medical conditions.
The Senior Regulatory Affairs Specialist combines knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured, or distributed to meet required regulations. They are a small, private, and well-funded medical device company seeking a hands-on Senior Regulatory Affairs Specialist to support the Company’ s regulatory activities across a variety of programs.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Senior Regulatory Affairs Specialist
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Assist with the acceptability of quality, preclinical and clinical documentation for submission filing.
- Assist in writing, preparing, and managing regulatory submissions and filings required for U.S. FDA and other international authorities (i.e. 510(k), CE Marking, Health Canada License, etc.)Evaluate changes to existing products for impact on global regulatory affairs submissions.
- Compile, prepare, review and submit regulatory submission to authorities.
- Monitor impact of changing regulations on submission strategies and update internal stakeholders.
- Monitor applications under regulatory review.
- Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
- Provide input on technical guidance and regulatory requirements to communicate with internal teams.
- Working with the Senior Director of RA/QA manage and execute preapproval compliance activities.
- Support product development teams with regards to implementation of international regulatory requirements.
- Oversee processes involved with maintaining annual licenses, registrations, listings.
- Working with the Senior Director of RA/QA ensure compliance with product post marketing approval requirements.
- Working with the Senior Director of RA/QA Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies.
- Working with the Senior Director of RA/QA report adverse events to regulatory agencies and internal stakeholders.
- Working with the Senior Director of RA/QA Provide regulatory input for product recalls and recall communications.
- Maintain and update regulatory affairs procedures and changes.
- Help with continuous improvement of the submission process.
- Bachelor’ s degree in a scientific discipline; advanced degree and RAC (Regulatory Affairs Certificate) preferred.
- Five or more years’ experience in regulatory affairs with direct project management responsibilities.
- Experience in assisting the development, writing and submittal of successful IDE/510(k)/PMA/De Novo submissions.
- Must have prior working experience with application processes for 510ks, Health Canada Application and CE Mark technical files.
- Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, and 21 CFR 820.
- Knowledge of software development and software quality as it relates to regulatory submissions a plus.
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat.
- Excellent organizational and negotiation skills as well as attention to detail.
- Excellent oral and written communication skills.
- Ability to work independently as an individual contributor and in a team environment.