Regulatory Affairs Specialist

Regulatory Affairs Specialist 

Location: J&J Pinewood Campus, Wokingham

Duration: 12 months initially

Hours: Full time

Imagine your next project as a Johnson & Johnson, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

roles and responsibilities

In this role, you will ensure that regulatory compliance is met and maintained in the UK / Ireland and ensuring the J&J standards are met. This will involve: 

• 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

• Expert in JnJ internal systems to maintain market access

• 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

• Submitting license applications to authorities to strict deadlines

how to succeed

You will have medical device knowledge, proven ability of interpreting legislation and impact to meet commercial needs. Excellent communication skills and interpersonal skills and a prove success at meeting strategic goals and KPIS. You will also bring knowledge and skills in:

• 2-3 years experience in medical devices

• Brexit Requirements and Legislation

• MDD Directive

• MDR Regulation

• High degree of initiative.

• Team player, fosters the strength of a network

• Communication and negotiation skills.

• Open minded, listens to others

• Customer focused

• Able to manage complexity and Matrix organization

• At ease in International environment.

• Fluent in English 

• Well organized, sense for detail

• Diplomacy

• Degree of Pharmacist or Scientific Degree or Law Degree

details:

This role offers a very competitive hourly rate. This contract will run for a 12 month period. This role is maternity cover which may go over the 12 month period.

Hybrid working style offered.

Flexi hours available.

you are welcome here

J&J is 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.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE & Umbrella options are available. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

Diversity, Equity & Inclusion

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 are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each 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”.