Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
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$ 91350 - 146160
1 Vacancy
Job Description
Job Title
Senior Regulatory Affairs SpecialistJob Description
Senior Regulatory Affairs Specialist (Ultrasound)
The Senior Regulatory Affairs Specialist recommends process improvements updates regulatory SOPs and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision they contribute to complex strategies support audits and guide junior team members. The role also manages change activities for sustaining products ensuring regulatory partners are informed of key updates.
Your role:
- Serve as RA Representative on project teams develops regulatory submission strategies for new product launch and provides 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.
- Maintain regulatory documentations to support compliance with regulatory requirements. Fulfills selected requirements under the European MDR MDD Japan PAL and Canada CMDR etc. as defined within SOPs and other documents.
Youre the right fit if:
- Youve acquired 5 years of experience in the medical device regulatory affairs and/or quality assurance field. Experience authoring SaMD or SiMD submissions strongly preferred. Experience authoring US 510k and EU MDR Tech Files required.
- 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 worldwide registrations clinical trials and software development/regulatory submissions and authoring 510Ks.
- You have a bachelors degree or higher in a related field. RAPS RAC preferred.
- You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for thisOffice/Remoteposition.
How we work together
We believe that we are better together than apart. For our office-based teams this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companys facilities. Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.
This is an office-based role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters and we wont 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.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Learn more about our culture.
Philips Transparency Details
The pay range for this position in Reedsville PA is $87000 to $139200.
The pay range for this position in Plymouth MN is $91350 to $146160.
The pay range for this position in Bothell WA and Cambridge MA is $97440 to $155904.
The actual base pay offered may vary within the posted ranges 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.
Company relocation benefits will not be provided for this position. For this position you must reside in or within commuting distance to posted locations.
#LI-PHI
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 including Disability/Vets and maintains a drug-free workplace.
Required Experience:
Senior IC
Employment Type
Full-Time
