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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 method to manage their blood pressure effectively. We invite you to contribute to our mission and positively influence the lives of individuals worldwide.
The Principal Regulatory Affairs Specialist will serve as a key authority within a dynamic Regulatory Affairs team, playing a vital role in shaping regulatory strategies, preparing submissions for the U.S. and major international markets, and securing approvals for the ReCor Medical product range.
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, as well as 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, articulating regulatory strategies effectively.
- Review and authorize internal engineering documentation and change orders.
- Support marketed products as needed, including the evaluation of labeling, promotional materials, product modifications, and related documentation.
- Lead regulatory compliance initiatives related to product requirements, including WEEE, Prop 65, REACH, and RoHS.
- Develop and implement processes for maintaining annual licenses, registrations, and listings, ensuring alignment with regulatory and business needs.
- Drive the creation of internal procedures, templates, style guides, and continuous improvement initiatives relevant to the function.
- Interpret new or existing regulatory requirements (U.S., EU, OUS) in relation to the product portfolio and regulatory quality system procedures.
- Ensure compliance with U.S. Food and Drug Administration (FDA), EU, and international regulations, along with 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 established timelines and budgets.
- Supply business and product information to international regulatory teams to facilitate the development of strategies for global commercialization.
- 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.
- Prior experience with U.S. IDE submissions, CER, PMS, and PMCF.
- Knowledge of MDR requirements and clinical evaluation standards is essential.
- Ability to manage multiple priorities and oversee programs with minimal supervision.
- Experience with medical device hardware and software requirements, including software regulations.
- Proven ability to thrive in a dynamic, cross-functional team environment.
- Demonstrated collaboration and leadership capabilities in team settings.
- Strong understanding of design control and change control processes.
- Experience in reviewing design specifications and other technical documentation.
- Excellent interpersonal and communication skills, both verbal and written.
- Ability to identify potential risks and escalate issues as necessary.
- Self-motivated with exceptional time management skills.
- A strong team player, willing to collaborate effectively.
Salary range: $142,795 - $192,415 annually, with level and title commensurate with experience, skills, education, and training.
At Recor Medical, we prioritize the health and safety of our employees and foster a collaborative environment essential for the innovation of our pioneering technology.
As an equal opportunity employer, Recor Medical values diversity and is committed to creating an inclusive environment for all employees.
