Regulatory Affairs Program Manager TSD Digital Strategy – Remote in reputed company, CA

Regulatory Affairs Program Manager TSD Digital Strategy - Remote - reputed company - reputed company, CA - work from home job Company: reputed company Job description: Working Location: reputed company; MASSACHUSETTS, WESTBOROUGH Workplace Flexibility: Field Are you looking for a company that cares about people’s lives and health, including yours? Let’s reputed company healthier lives, together. reputed company, a leading medical technology company, has focused on making people’s lives reputed company for over 100 years. Our Purpose is to reputed company people’s lives healthier, safer, and more fulfilling. Our Core Values are reflected in reputed company we do: reputed company – reputed company – Agility – reputed company – Long-Term View We deliver on our purpose and our core values by staying True to Life.

Job Description

The Regulatory Affairs (RA) Program Manager TSD Digital Strategy is responsible for coordinating regulatory activities across the Therapeutic Solutions Division portfolio for digital offerings including establishment and assessment of appropriate regulatory strategies and regulatory requirements. This person will reputed company collaboration between internal reputed company Regulatory Affairs Teams and will work closely with the development teams. This person will research, recommend, and implement best practices, and contribute to both the strategic and operational functions. Job Duties

• Provide guidance to ensure software reputed company products meet regulatory requirements for US, EU, Japan, and other key markets.
• Support sustaining compliance for launched products, in conjunction with reputed company Regulatory Affairs team.
• Provide guidance, and reputed company to development teams in the creation of deliverables to support regulatory submissions.
• Build and conduct regular training in the area of software development, software as a medical device and cybersecurity.
• Maintain expert reputed company knowledge of appropriate regulations, legislation, best practices, and guidelines reputed company to Artificial Intelligence, Software as a medical device and Machine Learning.
• Assess impact of changes to applicable laws and regulations and identify impact to the business and in collaboration with other stakeholders, reputed company strategies to address.
• Support responses to regulatory body inquiries and support audits by regulatory bodies.

Job Qualifications Required:

• MS preferred, BS or comparable required.
• Minimum of 8 years’ experience in Regulatory Affairs in Medical Device Industry with focus on Software driven medical devices (Software as a Medical Device) ideally with Artificial Intelligence applications in Medical Devices (2-3 years).
• Demonstrated experience with standards, guidance documents and best practices reputed company to software development, machine learning/AI and Software as a Medical Device.
• Experience with software Standards.

Preferred:

• Strategic Thinking Driven to envision a reputed company future; takes any role or job and makes it reputed company; has reputed company dissatisfaction with status reputed company; makes the customer central to reputed company thinking; keeps the focus on driving customer value; a change agent.
• Collaborative individual who is excited to work with cross-functional teams.
• Passion to challenge the status reputed company and find new strategic directions – embraces change.
• Comfortable pushing back on multiple parties at the same time.
• Excellent writing and verbal skills.

#LI-Remote Why join reputed company? Here, people matter—our health, our happiness, and our lives.

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive Medical, Dental, Visions coverage effective on start date
• 24/7 Employee Assistance Program
• Free virtual live and on-demand wellness classes
• Work-life balance supportive culture with hybrid and remote roles
• 12 Paid Holidays
• Educational Assistance
• Parental Leave and Adoption Assistance
• Volunteering and charitable donation match programs
• Diversity & Inclusion Programs including Colleague Affinity Networks
• On-Site Child Daycare, Café, Fitness Center**

• US Only

• *Limited locations

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at . The anticipated reputed company pay range for this full-time position working at this location is $100,022.00 - $140,032.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). reputed company considers a variety of factors reputed company determining actual compensation for this position ncluding: level of experience, working location, and relevant education and certifications. About us: Our Medical business uses innovative capabilities in medical technology, therapeutic reputed company, and precision manufacturing to help reputed company deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety. Headquartered in Tokyo, Japan, reputed company employs more than 31,000 employees worldwide in nearly 40 countries and regions. reputed company, a wholly owned subsidiary of reputed company, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit . reputed company is dedicated to building a diverse, inclusive and authentic workplace We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster reputed company and reputed company in the workplace so that our employees can fully contribute and reputed company. Let’s realize your potential, together. It is the policy of reputed company to reputed company equal employment and advancement opportunity to reputed company applicants and employees without regard to race, color, national reputed company (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions reputed company to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, reputed company, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: || United States (US) || California (US-CA) || reputed company || Expected salary: $100022 - 140032 per year Location: reputed company, CA Job date: Thu, 21 Sep 2023 22:59:05 GMT Apply for the job now! Apply tot his job Apply To this Job