Sr Manager, Regulatory Affairs
Great innovations start with the people that are passionate and skilled enough to create them. As a diversified health and well-being company, Philips focuses on improving people’s lives through those timely and meaningful innovations.
Work independently and as part of the RA Management Team on RA duties, and delegate, as applicable, processes and roles outlined below.
- Lead Regulatory Group or Project teams for Regulatory Projects with Business Unit Impact, to include the direct or indirect management of 7+ subordinate personnel, the development of executable Quality Plans, coordination with partnering functions/departments/resources and the management of the associated schedule and budget.
- Creation and execution of Regulatory Strategies and Plans for assigned products in the Domestic, Mature, and Emerging Markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers.
- Manages assigned Regulatory Affairs Budget.
- Process Owner for Regulatory QSPs and WIs.
- Develops subordinate Regulatory personnel and reviews assigned project outputs.
- Conducts Biannual Review of Regulatory QSPs and WIs.
- New Product Licensing and Registration submissions in the Domestic and Mature Markets (US, EU, CAN, AU)
- Create and/or lift Regulatory Restrictions based on the Regulatory status of assigned products, as needed.
- German Reimbursement submissions
- Provides document support to the Emerging Markets team for international product registration
- Tracks pending domestic and global regulatory changes, develops and executes quality plans to minimize impact to the Business Unit.
- Maintains expertise in domestic and foreign regulations and standards, with a focus on assigned products and regional focus on the US (FDA), EU (MDD), CA (Health Canada), and AU (TGA).
- Provides Regulatory Training to business units on regulations and standards as they apply to assigned products / business units.
- Conducts Regulatory Intelligence Analysis on specific assigned regions or content and briefs the business unit management teams on results.
Business Support – Manage a Regulatory Affairs Group of 3 to 6 personnel tasked with providing direct project support for registration and licensing to the Emerging Markets group for all registrations and licensing. Manage Group and Project Budget and Plans for Regulatory Projects with impact at the Business Unit Level. Manage the assignment, objectives, and development of the assigned International Regulatory Team.
Quality Culture/Process Improvement – Identify areas for improvement for efficiency and compliance in the internal processes, work instructions, and forms and apply technical expertise to lead process improvement efforts on Hoshin and Improvement teams. Develop a culture of Quality at the Business Unit level. Develop and Mentor subordinate Project Manager(s) on Process Improvement techniques.
Training – Maintain technical expertise in core Regulatory functions and secondary Quality functions including all applicable QSPs, WI, Forms, Philips training, and regulatory body requirements. Train and Mentor subordinate Regulatory Personnel. Conduct Business Unit Level Regulatory training for Regulatory and Non-Regulatory personnel.
Regulatory Proficiency – Maintain expertise in the interpretation of domestic and foreign regulations and laws as they apply to the licensing, registration, manufacture, shipping, and sale of assigned products, with a special focus on Emerging (“Rest-of-World”) markets vs. mature markets: USA, Canada, EU, Japan, and Australia. Conduct Regulatory Intelligence analysis to domestic and foreign markets to identify trends in regulation interpretation and compliance issues. Serve as SME in Regulatory Affairs for Internal and External Quality Audits.
At Philips we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Innovation is driven by gaining insight to the needs of the people who use our sleep and respiratory solutions. This tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in the markets we serve.
Here at Philips WE ARE Working Together for a Better Tomorrow
Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.
We are looking for
B.S. or equivalent in Engineering, Life sciences, or other similar technical field. Master’s degree preferred. RAC preferred.
Minimum of 10 years of experience within Medical Device industry. Duties and tasks reflect variety and complexity.
Must have experience in:
- Supporting and providing regulatory expertise to assigned product development projects from technical approach to post marketing phase
- Creating and executing Regulatory Strategies and Plans for assigned products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers
- Preparing and submitting 510(k)'s, IDE's and other product submissions according to FDA guidelines
- Creating European Technical File and Declaration of Conformity documents (MDD, R&TTE, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines
- Reviewing and approving product labeling plans, labeling, and marketing communications
- Supporting the international regulatory team with inputs, as needed, into the registration packages they prepare
- Supporting internal and external quality audits; participate as a member of PMRA and CAPA teams for Corrective and Preventative Actions
Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Not yet ready to apply? That’s okay! Learn more about us by joining our Talent Network on LinkedIn or following us on Twitter at @PhilipsJobsNA.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
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