Regulatory Affairs Specialist Ii

**DePuy Synthes, Inc **., part of the Medical Devices sector within Johnson & Johnson, is recruiting for a **Regulatory Affairs Specialist II **for the Joint Reconstruction team. _This role will work a Flex/Hybrid schedule and must be located within a commutable distance of Warsaw, IN, Raynham, MA, or Leeds, UK. _

**About Johnson & Johnson**

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.
- 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.

**Qualifications**:
**Required Qualifications**:

- Minimum of a Bachelor’s Degree **required **, Advanced Degree _strongly preferred _. Desired fields of study include sciences, biomedical engineering, medical/scientific writing, or public health administration.
- Minimum of 3+ years of relevant regulatory experience is **required **; Medical Device experience _highly desired _.
- 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 _strongly 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.
- 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.