Regulatory Affairs (RA) Associate
- Reference: Regulatory Affairs (RA) Associate
- Closing Date: 01/03/2023
- Type: General Application
Job Title: Regulatory Affairs(RA) Associate
Reporting To: Regulatory Affairs (RA) Advisor
Direct Reports: N/A
Working Hours: Standard, Non-Shift, Monday to Friday
Start Date: Jan 2023
We Are Welland
Welland Medical brings to market the best and most innovative products that enhance the lives of people living with a stoma across the world. Investing in the most talented people, collaborating to create world- class, ground-breaking products and services devoted to improving peoples’ lives. We are passionate about making a difference in the world. Our reputation is based on a tradition of improvement, ethical leadership, and total commitment to quality and safety. Welland Medical Ltd®, established in 1988 is part of the CliniMed® Group, and has over 250 colleagues committed to enhancing people’s lives.
We collaborate by embracing differing perspectives to make better decisions and continuously improve.
We pride ourselves on our innovative spirit by creating novel solutions within the workplace and in stoma care.
We commit to empower and respect each other, ethically, honestly and with fairness.
We are passionate about recognising talent and providing an equal and supportive workspace for all to thrive.
We commit to setting the highest standard of quality in everything we do to enhance people’s lives every day.
Summary Of The Role:
This is an excellent opportunity to join a rapidly growing global medical device manufacturer, with our headquarters based in Manor Royal, Crawley, in our purpose built premises.
We are looking for someone to work in a proactive team to ensure compliance to the applicable regulations, standards and guidance (including EU MDR, UK MDR and BS EN ISO 13485) across the business by managing the collation, creation, and maintenance of technical information, and by supporting the rest of the Regulatory Affairs team to complete projects, maintain product registrations, and execute other required tasks.
Main Duties and Responsibilities
As part of your role at Welland, you will be fully integrated within the Quality Assurance and Regulatory Affairs (QARA) team, with focus and ability to:
- Create, maintain, and update technical files – Collate technical information and data to use in the maintenance or creation of technical files in accordance with change control and new product development
- Prepare declarations of conformity (DoC’s)
- Collate and prepare data to support risk management activities in accordance with BS EN ISO14971, execute any resulting actions
- Maintain product registrations with agencies and systems when required
- Become point of contact with the Sales department for customer enquiries and co-ordinate product information required for registration and product tenders
- Support new product development as necessary.
- Support the rest of the Regulatory Affairs team with projects and other planned tasks.
- Co-ordinate and support tasks with external contacts, as directed by the rest of the Regulatory Affairs team.
- Collate data to support preparation for clinical evaluation plans.
- Support the completion of regulatory tasks linked to key company projects.
- Help to prepare product information specifications and ensure these are kept up to date.
- Monitor development of and changes to relevant standards to ensure the business stays up to date and changes can be addressed.
A degree of flexibility is needed and the job holder may be required to perform work not specifically referred to above and which will be appropriate to the level of the role.
Our colleagues are at the heart of what we do. Our passion for our colleagues wellbeing is reflected in our values and we offer (and not limited to) the following perks to all our colleagues:
- Competitive company pension, that increases with length of service
- Health benefits
- Life insurance
- 25 holiday days plus statutory bank holidays
- Company Christmas shut down
- Discount at a number of high street retailers and other local discounts
- Complementarity company day
- Free onsite parking (including electric vehicle charging)
- Cycle to work scheme
This is a description of the job as it exists at present. All Job Descriptions are liable to variation in order to reflect any future role/obligations change and employee development.
For more information, please contact our recruitment team at firstname.lastname@example.org. A covering letter and CV are required with all applications.