Regulatory Affairs Specialist I

5 months ago

Leeds, United Kingdom Johnson & Johnson Full time

**Regulatory Affairs Specialist I**

**DePuy Synthes - Joints**

**Location - Office Based, Wokingham or Leeds**

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in the UK are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means **“ **You **Belong”**

**About Johnson & Johnson**

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.

**DePuy Synthes **, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Regulatory Affairs Specialist for the Joint Reconstruction team, located in Leeds, UK.

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 governmental Health Authorities in strategic ASPAC markets
- Represents Regulatory Affairs in cross-functional project teams to develop pragmatic strategies and implementation plans, established accountability for the preparation of regulatory submissions.
- Interprets regulatory requirements of licenses and authorizations for the maintenance of existing product registrations, including assessing the impact product changes have on the status of regulatory licenses in various markets.
- 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 practices for Regulatory Affairs processes.

**Qualifications**:
**What you will bring**:
**Education**:

- A minimum of a BA/BS is required. Equivalent work experience will be considered for the right applicant.

**Experience and Skills**:
Required:

- A minimum of three (3) years of relevant/regulated industry experience is required.
- Possess the ability to work independently and handle multiple priorities is required, recommend, influence, implement operational improvements.
- 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.

**Preferred**:

- Previous experience with ASPAC medical device regulations and Class II and III medical devices submissions is preferred. International regulatory experience is desired.
- Proven track record to influence and partner with diverse, multi-functional teams across geographic boundaries is preferred.

**Other**:

- Connect - Cultivates external relationships with regulators in key markets (in partnership with regions) and internally with R&D, Med Affairs, Clinical Affairs partners
- Shape
- Challenges the status quo and adapts to change, taking advantage of opportunities to have positive impact.
- Travel percentage - up to 5% (including international travel)

**What type of mark will YOU make?**

**What’s in it for YOU?**

It’s important to us that you feel you can bring your whole self to work; at Johnson & Johnson we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. As part of our offering, you will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life. Examples of this include online Digital GP, private healthcare, Retail Vouchers, Discounted & Subsidised Gym memberships and you can get to support community projects as part of our global Corporate Social Responsibility programme.

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