Regulatory Affairs Specialist I (DePuy Synthes) - Medical Device Business Services, Inc.

DePuy Synthes, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Regulatory Affairs Specialist I for the Joint Reconstruction team.

This preferred location for this role is Warsaw, IN but candidates may also reside within a commutable distance of Leeds, UK .

This role will work a Flex / Hybrid schedule with 3 days per week on-site, there is NO remote option. About Johnson & Johnson 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 https : / / www.jnj.com / . Regulatory Affairs Specialist will coordinate the day-to-day Regulatory Affairs operations as advised by the Associate Director related to New Product Introduction (NPI), product Lifecycle Management (LCM), and Change Management for strategic ASAPC markets such as Australia, China, Japan.

In addition, these jobs exhibit a degree of independent judgment and complete plans that directly impact the operational results of the business. Key Responsibilities :

• Manage activities concerned with the submission and approval of joint reconstruction products to government regulatory agencies in strategic ASPAC markets.
• Develop pragmatic strategies and implementation plans, establishes accountability for the preparation of regulatory submissions.

Prepare, draft and file regulatory submissions to support product approvals.

• Interact with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.
• Work independently and manage multiple projects simultaneously under fixed timelines,
• Interprets regulatory requirements and coordinates aspects of submission of licenses and authorizations for the maintenance of existing products, international registrations and dossiers including assessment of the impact product changes have on the status of regulatory licenses.
• Represents regulatory affairs in cross-functional project teams and plans schedules for regulatory results on a project and monitors project through completion.
• Ensure adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.
• Ensures organization compliance with all applicable regulations and J&J policies.

Assists with audits and inspections, as the need arises.

Assists in the development of improved and efficient processes practices for Regulatory Affairs processes.

Required Qualifications :

• Minimum of a Bachelors Degree is required; Advanced Degree is strongly preferred .
• Minimum of 1-2 years of relevant regulated industry (MedTech, Pharma, Consumer) experience is required.
• Possess the ability to recommend, influence, implement operational improvements, work independently and handle multiple priorities is required.
• Demonstrated strong analytical and problem-solving skills is required.
• A proven track record of developing and executing regulatory strategies that align with business deliverables is required.
• Previous experience with US and EU medical device regulations and Class II and III medical devices submissions is preferred.

International regulatory experience is highly desired .

• Proven track record to influence and partner with diverse multi-functional teams across geographic boundaries is preferred .
• Connect by cultivating external relationships with regulators in key markets (in partnership with Regions) and internally collaborating with the R&D, Med Affairs, Clinical Affairs partners.
• Challenges the status quo and adapting to change, taking advantage of opportunities to have positive impact.
• Travel percentage - up to 5% (including International travel) 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 .