Regulatory Affairs Specialist

3 weeks ago

Wokingham, United Kingdom Johnson & Johnson Full time

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”**Who are we?**
- Profound Change Requires Boldness.
- **Johnson & Johnson **is the largest and most broadly-based healthcare company in the world. We’re producing life-changing breakthroughs every day and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are crafting digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world.**Johnson & Johnson - MedTech**
- At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.- For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive and more personalized.We have an exciting role within our team as a
- **Regulatory Affairs Specialist **supporting our Ethicon and CSS businesses, based in either Wokingham or Leeds. (Hybrid role)**Purpose of the role**
- To _
- ensure that Regulatory Compliance is met and maintained in the UK/Ireland and that J&J standard requirements are met _

**What to expect**:

- Ensuring that the company's products comply with relevant legislation and standards- Keeping abreast of international legislation, guidelines, and customer practices- Keeping up to date with a company's product range- Working knowledge of medical devices regulatory documentation- Developing and writing clear strategies and arguments and explanations for new product licenses, modifications, and license renewals- Preparing submissions of license variations and renewals- Preparing submissions of registrations and variations to MHRA- Setting and communicating timelines for license variations and renewal approvals- Advising scientists and manufacturers on regulatory requirements- Reviewing company practices and providing advice on changes to systems. Liaising with, and making presentations to regulatory authorities-
**Qualifications**:
**Who are we looking for?**
- Proven expertise of medical device Regulatory Affairs on a European Basis- Ability of interpreting legislation and impact to meet commercial needs- Demonstrate an appreciation and understanding of the positive impact of regulatory in delivering business solutions- Excellent communication and interpersonal skills, ability to influence and motivate- Proven success at meeting strategic goals and KPIs- Brexit Requirements and Legislation- MDD Directive- MDR Regulation- Customer focused- Able to manage complexity and Matrix organization- At ease in international environment**What type of mark will**
**YOU**
**make?**
- By joining**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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