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Senior Regulatory Affairs Specialist
2 months ago
At Recor Medical, we are at the forefront of developing Ultrasound Renal Denervation (uRDN) therapy aimed at addressing hypertension, a significant cardiovascular risk factor globally. Our innovative Paradise uRDN System is designed to offer millions suffering from hypertension a non-pharmaceutical and minimally invasive solution to effectively manage their blood pressure.
The Senior Regulatory Affairs Specialist will serve as a key authority within a dynamic Regulatory Affairs team, tasked with shaping regulatory strategies, preparing submissions for the U.S. and major international markets, and securing approvals for the ReCor Medical product line.
Key Responsibilities:- Oversee post-market activities, ensuring compliance with EU MDR and MEDDEV standards, including the creation and maintenance of Clinical Evaluation documents for new products, along with updates to existing Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post Market Clinical Follow Up (PMCF) Plans/Reports.
- Act as the regulatory representative in clinical program teams, effectively communicating regulatory strategies.
- Review and authorize internal engineering documentation and change orders.
- Support marketed products by reviewing labeling, promotional materials, and documentation for product modifications.
- Lead compliance initiatives related to product regulations, including WEEE, Prop 65, REACH, and RoHS.
- Develop and implement processes for maintaining annual licenses, registrations, and listings, ensuring alignment with regulatory and business requirements.
- Drive the creation of internal procedures, templates, style guides, and continuous improvement initiatives within the department.
- Interpret regulatory requirements (US, EU, OUS) as they pertain to the product portfolio and quality system procedures.
- Ensure compliance with U.S. Food and Drug Administration (FDA), EU, and international regulations, as well as company policies and procedures.
- Stay informed about changes in regulatory agency requirements and provide training to stakeholders as necessary.
- Utilize organizational and planning skills to manage complex regulatory projects within set timelines and budgets.
- Collaborate with international regulatory teams to provide business and product information necessary for global commercialization strategies.
- Continuously assess, recommend, and implement improvements as required.
- Be prepared to undertake additional responsibilities as assigned.
- A Bachelor’s degree in life sciences or biomedical engineering is required; an advanced degree is preferred. Relevant certification (e.g., RAC from the Regulatory Affairs Professionals Society) is advantageous.
- A minimum of 10 years of experience in regulatory affairs within the medical device sector.
- At least 5 years of experience with CEP, CER, and PMCF processes.
- Prior experience with US IDE submissions, CER, PMS, and PMCF is essential.
- Familiarity with MDR requirements and clinical evaluation standards is necessary.
- Ability to manage multiple priorities and oversee programs with minimal supervision.
- Experience with medical device hardware and software regulations is required.
- Proven ability to work effectively in a dynamic, cross-functional team environment.
- Demonstrated collaboration and leadership skills in team settings.
- Strong understanding of design control and change control processes.
- Experience in reviewing design specifications and technical documentation.
- Excellent interpersonal and communication skills, both verbal and written.
- Capability to identify risk areas and escalate issues appropriately.
- Self-motivated with exceptional time management abilities.
- A strong team player, willing to collaborate effectively.
Compensation ranges from $142,795 to $192,415 annually, commensurate with experience, skills, education, and training.
At Recor Medical, we prioritize the health and safety of our employees and value diversity in our workforce. We are committed to equal employment opportunities and do not discriminate based on race, color, religion, national origin, age, sex, disability, or any other legally protected characteristic.
