Principal Regulatory Affairs Specialist
Location
Cambridge, MA | United States
Job description
JOB DESCRIPTION
Job Title
Principal Regulatory Affairs Specialist
Job Description
Principal Regulatory Affairs Specialist (U.S. Hub based, EST or CT)
The Principal Regulatory Affairs Specialist will function as a core member of multiple sustaining and new product development teams to provide timely and valued regulatory guidance (written and/or verbal) by owning the following tasks:
Your role:
- Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
- Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy.
- Responsible for product registration submissions/approvals for the US, Canada, EU and selected worldwide locations.
- Review and approve advertising, promotional items and labeling for regulatory compliance.
- Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
- Advises product design teams on regulatory strategy and requirements for specific new products/solutions.
- Lead a team of Regulatory members for assigned projects where Regulatory needs to provide Regulatory inputs including Regulatory impact/assessment as well as business impacts
Additionally, the Principal RA Specialist will:
- Communicate application progress to internal stakeholders. Collaborate with worldwide colleagues regarding license renewals and updates.
- Maintain regulatory files and tracking databases as required. Communicate with regulatory agencies as needed.
- Ensure standard and process compliance. Provide audit, CAPA and post market regulatory support. Mentor junior regulatory affairs personnel within HPM Regulatory by letting junior Regulatory Affairs Specialist through shadowing, reviewing Regulatory Strategy/Plan and Regulatory Submissions, and/or attending meetings together.
You're the right fit if:
- You’ve acquired 6+ years of experience in regulatory approvals and submittals (EU MDD, Health Canada, USA, etc.). Experience with 510(K) submissions, and Software as a Medical Device (SaMD) required. Familiarity with Artificial Intelligence and Machine Learning preferred.
- Your skills include proficient knowledge of domestic and international standards. Ability to manage multiple tasks and perform with accuracy and a high attention to detail.
- You have a bachelor’s degree or higher in Regulatory Affairs (preferred) or a science related field or equivalent experience in the medical device industry. RAC/RAPS certification preferred.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
- You’re an strong communicator (written and verbal) with an ability to effectively compose agency submissions, interface cross-functionally and complete assignments with minimal supervision. Proficiency in Microsoft Office required. May travel up to 5% annually, with possibly some international.
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.
- Learn more about our business .
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits .
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 $96,850 to $200,256
, 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.
Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to posted locations.
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Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
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