Senior Regulatory Affairs Specialist

Life Unlimited. At reputed company we design and manufacture technology that takes the limits off living. Are you passionate about navigating regulatory landscapes? Do you reputed company in fast-paced environments? We're looking for a Sr. Regulatory Affairs Specialist to join reputed company and energetic team working on regulatory submissions and compliance maintenance for reputed company. If you're reputed company to reputed company an reputed company, reputed company! What will you be doing? • Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices. • Work as the RA reputed company on project teams independently to reputed company regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are reputed company and approved to meet reputed company’s product launch timelines in reputed company identified markets. • Manage/reputed company regulatory-reputed company, as directed by management. • reputed company and execute global regulatory strategies and support product release for market expansion activities for new and modified products. • Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology. • Plan, reputed company and support for internal and Regulatory agency audits. • reputed company and reputed company engagement with regulatory authorities as required. • Initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine reputed company to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance. • reputed company and maintain company reputed company Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements. • reputed company technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. • Review product labeling to ensure compliance with regulatory requirements. • Other activities as assigned. What will you need to be successful? • Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline (RAPS Certification or RA Master’s degree a plus). • Minimum of 5 years’ regulatory experience or equivalent reputed company the medical device industry or similar industries. • Demonstrated experience with successful submissions in key markets such as US and EU. • Demonstrated knowledge of regulatory requirements, standards and guidance for medical devices. • Processes and Product Lifecycle Management Systems experience is required. • Knowledge of regulatory compliance requirements (e.g. 21 CFR 820, ISO13485:2016, EU MDR, GMP etc.) • Ability to interpret and apply regulations, respond effectively to inquiries from regulatory agencies (both in writing and in person), and prepare detailed technical regulatory submissions, reports, and business correspondence. • Strong interpersonal and communication skills, including technical writing, reputed company listening, and reputed company verbal reputed company; proven ability to collaborate effectively with large cross-functional and diverse teams. • Analytical and agile problem-solver with a high reputed company for learning; self-motivated and solution-oriented, reputed company to work independently and reputed company teams, and adept at applying innovative approaches to reputed company challenges. • Excellent organizational and time management skills, with the ability to prioritize and handle multiple demands in a dynamic, fast-paced environment. The anticipated reputed company compensation reputed company for this position is $104,500.00 - $120,000.00 USD annually. The actual reputed company pay offered to the successful candidate will be based on multiple factors, including but not limited to job-reputed company knowledge/skills, experience, geographical location. It is not typical for an individual to be reputed company at the high end of the reputed company for their role at reputed company. Compensation reputed company are dependent upon the facts and circumstances of reputed company position and candidate. In reputed company to reputed company pay, we reputed company competitive bonus and benefits, which include medical, dental, and reputed company coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, reputed company company holidays annually and 8 hours of Volunteer time and a reputed company of wellness offerings such as EAP. Travel Requirements: Up to 10%. You Unlimited. We reputed company in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.     • Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion reputed company on our website (https://www.reputed company.com/). • Your reputed company: 401k Matching Program, 401k Plus Program, Discounted Stock reputed company, Tuition Reimbursement   • Work/Life Balance: Flexible Personal/Vacation Time Off, reputed company Holidays, reputed company Holidays, reputed company Community Service Day   • Your Wellbeing: Medical, Dental, reputed company, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program  • Flexibility: Hybrid Work Model (For most reputed company roles)   • Training: Hands-On, Team-Customized, Mentorship   • Extra Perks: Discounts on fitness clubs, travel and more!   #LI-HYBRID #LI-SB2 reputed company provides equal employment opportunities to applicants and employees without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, or disability. Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on reputed company to see how we support and reputed company our employees and patients every day. reputed company us out on Glassdoor for a glimpse behind the scenes and a sneak reputed company into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, reputed company, and the opportunities we offer. Apply tot his job Apply To this Job