Senior Regulatory Specialist at Philips ensures compliance with worldwide clinical device suggestions, helping product development, layout modifications, and safety corrections. They lead 510(okay) submissions, pre-sub conferences, and EU MDR Technical Documentation schooling, operating intently with regulatory bodies for approvals. Acting as a Regulatory SME, they offer strategic steerage to teams, display screen regulatory changes, and implement compliance techniques. Senior Regulatory Specialist at Philips Responsibilities include product sickness assessments, CAPAs, and gadget enhancements. With robust know-how in FDA, EU MDR, and ISO 13485, they pressure regulatory techniques, mentor institution human beings, and collaborate cross-functionally to deliver solid, compliant, and innovative healthcare answers.
- Role: Senior Regulatory Specialist
- Company: Philips
- Qualifications: Minimum of a bachelor’s degree in engineering or a related scientific field
- Experience: 7 – 10 Years
- Salary: ₹9.9 Lakhs to ₹20.0 Lakhs per year
- Location: Bengaluru
Senior Regulatory Specialist at Philips
The Senior Regulatory Specialist plays a pivotal function in making sure compliance with international regulatory standards for scientific gadgets. Senior Regulatory Specialist at Philips This character will expand and put in force regulatory techniques for brand-spanking new product improvement, layout adjustments, and challenge safety corrections across the U.S., EU, and the Rest of the World (RoW). They are tasked with authoring regulatory submissions, together with 510(okay) packages, important pre-submission conferences, growing EU MDR Technical Documentation, and getting equipped with Health Canada license applications. Senior Regulatory Specialist at Philips The function requires lively engagement with regulatory government and capable bodies, facilitating smooth opinions and approvals.
Philips overview
Philips is a global chief in health technology, devoted to enhancing people’s lives through sizeable improvements. With a focal point on affected person care, diagnostics, and personalized fitness, Philips develops cutting-edge solutions in scientific gadgets, imaging systems, and healthcare informatics. Senior Regulatory Specialist at Philips Guided via using its project to make the vicinity healthier and further sustainable, Philips combines clinical expertise with superior generation to cope with critical healthcare worrying situations. The enterprise employer’s collaborative approach fosters innovation, ensuring purchaser-centric solutions. Senior Regulatory Specialist at Philips Operating in over 100 international places, Philips is dedicated to enhancing healthcare outcomes whilst adhering to the very nice standards of fine, protection, and regulatory compliance.
Skills for Senior Regulatory Specialist at Philips
Regulatory Knowledge: Expertise in FDA 21 CFR 820, ISO 13485, EU MDR (2017/745), and unique international clinical device regulations.
Regulatory Submission Experience: Proficiency in making equipped 510(good enough) submissions, EU MDR Technical Documentation, and Health Canada license applications.
Regulatory Strategy Development: Growth ability and execute regulatory techniques for today’s products, layout changes, and subject safety corrections.
Project Management: Strong ability to control and lead regulatory initiatives across product traces, from the concept to the transport section.
Cross-sensible Collaboration: Working efficaciously with product development, first-rate guarantee, and distinct departments to ensure regulatory compliance at some point in the product lifecycle.
Communication Skills: Excellent written and verbal communique abilities for making geared-up regulatory files, speaking with regulators, and presenting guidance to groups.
Global Regulatory Landscape Monitoring: Keeping up with and adapting to worldwide regulatory modifications, at the side of the U.S., EU, and RoW.
Problem-Solving and Decision-Making: Ability to interpret complex regulatory requirements and devise answers that align with commercial enterprise dreams.
Mentorship and Coaching: Experience mentoring junior regulatory bodies of people and supplying guidance to ensure regulatory knowledge is shared at some point in businesses.
Attention to Detail: High interest in the element while reviewing regulatory documents, product infection tests, labeling, and advertising and advertising materials for compliance.
Health Hazard Evaluation: Expertise in assessing the effect of defects or troubles on health and safety, and figuring out appropriate corrective moves.
Quality System Regulations (QSR) Knowledge: In-depth data on pleasant structures and the way they practice regulatory submissions and compliance.
Negotiation Skills: Ability to barter with regulators to ensure favorable outcomes in submissions and interactions.
Process Improvement: Experience in figuring out regions for internal method optimization to beautify overall performance and compliance.
Risk Management: Knowledge of hazard management techniques for assessing and mitigating functionality regulatory or compliance problems.
Organizational Skills: Ability to manage a couple of regulatory submissions and obligations simultaneously whilst meeting last dates.
Technical Writing: Proficient in drafting incredible, precise regulatory documents that follow global necessities.
Knowledge of Labeling and Claims: Understanding of regulatory requirements associated with product labeling, advertising substances, and substantiation of claims.
Adaptability: Ability to quickly adapt to changing regulatory necessities and company standards.
Leadership and Influence: Experience fundamental organizations and influencing others without direct authority to achieve regulatory compliance desires.
Key Responsibilities of a Senior Regulatory Specialist at Philips
Regulatory Strategy Development:
- Develop and put into impact regulatory strategies for modern-day product development, design adjustments, and subject protection corrections throughout a couple of regions (US, EU, RoW).
- Provide regulatory entry from the idea phase to product delivery to ensure certain regulatory compliance.
Regulatory Submissions:
- Author and manage regulatory submissions, which encompass 510(adequate) applications, EU MDR Technical Documentation, Health Canada license applications, and international registrations.
- Lead pre-submission meetings and interactions with regulatory authorities, ensuring clean compare and approval techniques.
Cross-sensible Collaboration:
- Work closely with product development, engineering, great, and manufacturing groups to provide regulatory steering in the direction of the product lifecycle.
- Ensure that regulatory necessities are included in the format, improvement, and manufacturing techniques.
Regulatory Expert Guidance:
- Act as a Regulatory Subject Matter Expert (SME) and offer strategic guidance to the regulatory affairs crew and different departments.
- Advise corporations on regulatory requirements, industry requirements, and super practices.
Monitor Global Regulatory Changes:
- Keep updated with evolving worldwide regulatory landscapes, on the facet of modifications in FDA policies, EU MDR, and different international requirements.
- Communicate and interpret those modifications to the corporation, ensuring compliance at some point in regions.
Defect and Safety Assessment:
- Support product illness tests, problem impact opinions, fitness threat assessments, corrections, and removals.
- Lead or take part in Corrective and Preventive Action (CAPA) strategies, ensuring regulatory necessities are met at some unspecified time in the future of product modifications.
Compliance Review:
- Review labeling, advertising and marketing substances, and claims substantiation evidence to ensure compliance with global regulatory necessities.
- Ensure that all promotional and product materials meet community and global regulatory requirements.
Process Improvement:
- Identify areas for development in internal regulatory strategies, painting instructions, and bureaucracy to enhance efficiency and compliance.
- Lead or contribute to method improvement obligations, and the use of trade in the regulatory affairs department and across business enterprise gadgets.
Regulatory Training and Mentorship:
- Provide education, mentoring, and training to junior regulatory affairs group people, improving their regulatory know-how.
- Promote understanding sharing and assist build regulatory abilities for the duration of groups.
Risk Management:
- Contribute Senior Regulatory Specialist at Philips to the identification and mitigation of regulatory dangers associated with product improvement, manufacturing, and marketplace launch.
- Assist in growing chance manipulation techniques to reduce non-compliance and safety risks.
Stakeholder Engagement:
- Lead and manipulate relationships with regulatory bodies and capable government, advocating for the company’s pursuits and making sure of high-quality interactions.
- Act because the number one thing of touch for all regulatory inquiries associated with assigned tasks.
Document and Report Preparation:
- Prepare, evaluate, and place super regulatory documents, Senior Regulatory Specialist at ensuring clarity, accuracy, and compliance with regulatory standards.
- Maintain up-to-date facts of all regulatory submissions, approvals, and correspondence.
Strategic Planning:
- Contribute to the development of lengthy-time period regulatory techniques aligned with commercial business enterprise goals and market desires.
- Support management in setting regulatory priorities and meeting strategic business enterprise dreams.
Global Regulatory Intelligence:
- Gather intelligence on regulatory tendencies, competitor activities, and emerging requirements in international markets.
- Provide Senior Regulatory Specialist at Philips insights to the economic organization and product development teams to manual market entry and product innovation.
Travel and Representation:
- Participate in regulatory conferences, organization meetings, and workshops as needed, requiring occasional excursion (up to 20%).
- Represent the employer’s regulatory hobbies in outside forums and ensure visibility with key regulatory organizations.
Benefits at Philips
- Comprehensive Health Coverage: Inclusive of medical, dental, and vision insurance for personnel and their households.
- Retirement Plans: Competitive 401(k) retirement plans with organization contributions.
- Paid Time Off: Generous tour, sick go away, and paid vacations, collectively with options for parental go away.
- Flexible Work Arrangements: Opportunities for hybrid or far-flung paintings to sell work-existence balance.
- Career Development Programs: Access to education, certifications, and mentoring for the professional boom.
- Employee Assistance Program (EAP): Support for highbrow health, financial planning, and prison services.
- Health and Wellness Programs: On-web website gyms, fitness instructions, and nicely-being incentives.
- Diversity and Inclusion Initiatives: Programs to create a supportive and inclusive place of work and way of life.
- Employee Discounts: Discounts on Philips services and products.
- Global Opportunities: Chance to work on global obligations and roles at some point in terrific areas.
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