- Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provide regulatory guidance to the project teams.
- Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.
- Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
- Maintain regulatory documentations to support compliance with regulatory requirements.
- Participants in internal and external Quality System Audits.
- Fulfills selected Quality System requirements as described within the Quality Systems (related to regulatory assessments, promotional materials review, change order reviews, CAPA reviews).
- Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents.
- You've acquired 5+ years of experience in medical device regulatory or quality assurance field
- Your skills include knowledge of quality system requirements and FDA and/or International product approval process, demonstrate a track record in obtaining FDA clearances and/or worldwide registrations, clinical trials and software development/regulatory submissions is a plus and authoring 510K's.
- You have a Bachelor's degree in life sciences or a related field
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits.
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Senior Regulatory Affairs Specialist - Plymouth, MN, United States - Philips
Description
Job TitleSenior Regulatory Affairs SpecialistJob Description
Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.
In this role you have the opportunity to
Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables.
Your role:
You're the right fit if:
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
Philips Transparency Details
The pay range for this position is $77,000,000 to $136,000, Annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
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