Regulatory affairs Empleos en Saint paul mn

Job Title

Senior Regulatory Affairs Specialist

Job Description

Sr. Regulatory Affairs Specialist

In this role you

The Senior Regulatory Specialist will provide regulatory support for our Image Guided Therapy business including direct submission to health authorities and indirect project management of worldwide registrations. You will execute regulatory strategy to support the growth within the Structural Heart / Heart Rhythm Management category

Your role :

• Preparing comprehensive regulatory strategies for potentially complex new devices, and significant post market changes (such as line extensions, indication expansions, and substantive process / design changes). As necessary, reviews complex regulatory strategy issues with RA management.
• Preparing regulatory filings for the US, EU, and Canada, potentially including FDA Pre-Submissions (and similar) for new products, as well as post-market changes. Maintain proficiency in worldwide regulatory requirements, particularly within US, EU, Canada, Japan, and China.
• Following Philips' Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD / MDR, CMDR, MDSAP, and all other applicable regulations.
• Able to professionally negotiate and lead meetings (eg Pre-Subs) directly with regulatory agencies (e.g. FDA, Notified Bodies, etc.) on regulatory filings at the reviewer or management (eg Chief or Deputy) level.

You're the right fit if :

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 company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.

This is an office role.

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.

Philips Transparency Details

The pay range for this position in Plymouth is $75,000 to $130,000, Annually.

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 Plymouth, MN.

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 / Disabled / Veteran and maintains a drug-free workplace.