Regulatory Affairs Specialist

Regulatory Affairs Specialist 

Location: Wokingham (Hybrid working)

Duration: 12 months

Hours: The standard work hours are 40 per week, but we are open to considering candidates available on a part-time basis.

Pay rate range: £19 - £23.50

Imagine your next project working closely with the regulatory affairs director to get ready for the imminent release of new legislation in the field of medtech.

roles and responsibilities

Ensure that Regulatory Intelligence is gathered and analysis performed on the future state of legislation in the UK.

Ensure that J&J standard requirements are met

This will include:

• Keeping up to date with the company's product range

• Understanding of medical devices regulatory documentation

• Reviewing new UK legislation and identifying changes, especially on the recognition model and new registration requirements, focus on inputs/requirements to the plan.

• Reviewing local operating company practices and providing advice on required changes to the process & procedures, implement such changes.

• Preparing submissions of registrations and variations to MHRA in the current state and preparing for the future state.

• Setting and communicating timelines for licence variations and renewal approvals

• Submitting licence applications to authorities to strict deadlines

how to succeed

We seek an individual with a proven track record and expertise in medical device legislation, including MDD, MDR, and UK SI. The ideal candidate will possess the ability to skillfully interpret legislative changes and their implications.

You will also bring:

• Degree of Pharmacist or Scientific Degree or Law Degree

• Worked in a Regulatory position for five years ideally.

• Proven expertise of medical device Regulatory Affairs on a European & UK Basis

• Proven 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

• Experience of interpreting legislation into an implementation plan.

• Brexit Requirements and Legislation

• MDD Directive

• MDR Regulation

• Excellent communication and interpersonal skills, ability to influence and motivate

• Proven success at meeting strategic goals and KPIs

• 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 organisation

• At ease in an International environment.

• Fluent in English 

• Well organised, sense for detail

• Diplomacy

Benefits

This role offers a very competitive hourly rate. This contract will run for a minimum of 12 months.

you are welcome here

Johnson & Johnson 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. 

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”.