Staff/Principal Regulatory Affairs Specialist (Operations)
Palo Alto
Regulatory Affairs – Regulatory Affairs /
Full-time /
On-site
At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.
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 ReCor Medical 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.
$142,795 - $192,415 a year
Level and Title is commensurate with experience, skills, education, and training.
COVID-19 vaccination requirements
At Recor Medical, we care, we collaborate, we challenge, and we create. Pursuant to these core values, we are focused on the health and safety of our employees, as well as the teamwork essential for innovation of our pioneering technology. COVID-19 vaccines will be required for all ReCor US office employees effective June 10, 2021, as well as all new US office employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine.
Equal Employment Opportunity
At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
