The Regulatory Affairs Specialist II provides regulatory guidance to project teams in business planning and related submissions to support DePuy Synthes Arthroscopic Equipment Solutions products. Under minimal direction, the individual develops and performs regulatory strategies for significant change supplements and 510(k) registrations to support the continued commercialization of products in key countries. This role helps define the data and information needed for regulatory actions in conjunction with cross-functional teams. In addition, this candidate guides conformance with applicable regulations through the development of standard methodologies for Regulatory Affairs processes, procedures, and systems.

Key Responsibilities:

• Prepares responses to regulatory agencies' questions and other correspondence.

• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.

• Researches and collects data and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates.

• Advises on regulatory labeling requirements and specifications for modified products, and reviews product labeling to ensure compliance.

• Provides regulatory guidance and mentorship to project teams and responds to product information requests.

• Provides Regulatory Affairs support during internal and external audits.

• Assists in the development of standard methodologies for Regulatory Affairs processes.

• Responsible for communicating business-related issues or opportunities to the next management level and represents Regulatory Affairs on cross-functional project teams.

• Responsible for following all company guidelines related to health, safety, and environmental practices, as applicable.

• Responsible for ensuring personal and company compliance with all federal, state, local, and company regulations, policies, and procedures.

Qualifications

Required Qualifications:

• Minimum of a Bachelor's Degree is required; Advanced Degree strongly preferred. Desired fields of study include Biomedical Engineering, medical/scientific writing, or other Engineering focus.

• At least 3+ years of regulatory affairs or related/equivalent experience in the Medical Device sector.

• Experience with U.S. FDA Regulations and European Medical Device Regulations (and previous Medical Device Directives) is required.

• Demonstrated expertise in medical device regulatory requirements and processes.

• Outstanding project management skills, as demonstrated by competence in leading multiple projects simultaneously.

• Outstanding written and oral communication skills.

• Connects by cultivating external relationships with regulators in key markets (in partnership with Regions, Policy, and EU Strategy leads) and internally collaborating with SC, R&D, Clinical Affairs, and other partners.

• Shapes by driving strategies developed by the Regulatory Policy Team.

• Leads by acquiring and developing a complementary team of hard-working regulatory professionals and openly communicating in a constructive manner.

• Delivers results for timely clearances and approvals; leads changes in tasks and process improvements for regulatory matters.

• Experience in worldwide regulatory systems preferred.

• Previous medical device submission experience preferred.

• Demonstrated expertise in orthopedics and orthopedic device regulatory requirements preferred.

• Up to 10% domestic or international travel may be required.

The anticipated base pay range for this position is $74,000 to $119,600 based on experience. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

• Employees are eligible for the following time off benefits:

o Vacation - up to 120 hours per calendar year

o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

o Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com