Senior Regulatory Affairs Program Lead - Omaha, United States - Johnson & Johnson

Johnson & Johnson Omaha, United States

3 weeks ago

Description

Job Description - Senior Regulatory Affairs Program Lead W)
Senior Regulatory Affairs Program Lead

W
Description
Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a

Senior Regulatory Affairs Program Lead , to be located in

Cincinnati, Ohio; Raynham, MA; Raritan, NJ or Santa Clara, CA.
At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

The Senior Regulatory Affairs Program Lead executes the Regulatory Affairs platform strategy.

We support regional and country product registrations, monitor and assess impacts of product specific regulations for new products as well as lifecycle product registrations.

In this role, you will:
·

Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified global product launches and related regulatory activities.

Complete the preparation and submission of regulatory information required to obtain global market access, identifying risk and issues, effectively communicating timelines for project completion, and addressing issues that may impact registration status.

·

Execute on plans that directly impact the operational results.
·

Work closely with Research and Development, Medical Affairs, Quality Engineering, Product Management, Labeling, as well as global Regulatory Affairs affiliates.

·

Support clinical strategy and work with clinical teams to support regulatory submissions.
Qualifications
·

A minimum of a B.A. /B.S. within a technical related discipline is required
·

A minimum of 6 years relevant / regulated industry overall experience is required
·

A minimum of 4 years of medical device regulatory experience is required
·

Experience in medical devices containing software and electrical testing highly preferred
·

A demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required
·

Working knowledge and thorough understanding of how global regulations impact product registration is required
·

Experience with US and EU submissions required
·

Strong written & verbal communication and presentation skills is required
·

Collaborative work style in a highly matrixed environment is required
·

The ability to build and sustain productive partnerships across multiple platforms is required
·

The ability to evaluate new regulatory requirements as well as regulatory changes, and correctly assess business impact is preferred
·

Plan and execute complex projects through timely completion is required
·

The team will be based in Cincinnati, Ohio so this role may require up to 20% travel to other J&J MedTech sites
This job posting is anticipated to close on The Company may however extend this time-period, in which case the posting will remain available on

to accept additional applications.
For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $90,000 to $130,000. For Santa Clara, CA the anticipated base pay range for this position is $ 105,000 to $145,000.

The pay range is the anticipated pay range for the position to which you have applied, and that such factors, including but not limited to, internal equity and experience will be considered for any offer.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

Other Locations

Other Locations

NA-US-California-Santa Clara, NA-US-New Jersey-Raritan, NA-US-Massachusetts-Raynham
Organization

Organization

Ethicon Endo Surgery Inc (6041)
Job Function

Job Function

Regulatory Product Submissions and Registration
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.andEqual Employment Opportunity Posters GINA Supplement.

If you are an individual with a disability, please check ourpage for information on how to request an accommodation.
Disability Assistance
This site is governed solely by applicable U.S. laws and governmental regulations. Please see our. Use of this site constitutes your consent to application of such laws and regulations and to our. Your use of the information on this site is subject to the terms of our.

You should view thesection and the most recent SEC Filings in thesection in order to receive the most current information made available by Johnson & Johnson Services, any questions or search this site for more information.

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