Description
Job Location: Deeside CH5, UK
Job Location Type: Hybrid
Job Contract Type: Full-time
Job Seniority Level: Entry level
Company Overview:
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com
Job Summary:
The primary responsibilities of the position are to drive improvements in regulatory affairs processes, systems, and infrastructure whilst supporting regulatory strategy and registration across global markets and across the whole Regulatory Affairs group. Individuals will be expected to help drive regulatory processes and activities (such as regulatory intelligence, global registrations, review of marketing materials) and continue to develop strong working relationships with the rest of the RA group as well as internal and external customers. The person will be responsible for the management of global and regional regulatory projects including but not limited to the regulatory aspects of new product development, product life cycle changes to existing products.
Key Responsibilities:
- Take ownership of Regulatory requests received from internal and external stakeholders in support of global regulatory commercial activities including new renewal change submissions.
- Generate approve regulatory technical documents for various global markets in support of global regulatory commercial activities.
- Liaise with internal stakeholders to coordinate preparation documentation including technical legal documentation required in support globally.
- Generate execute strategies for phased launches new renewal change submissions other major projects whilst liaising managing internal external stakeholders defined timescale.
- Work with Regulatory colleagues local markets monitor pending process submissions communicate management identified delays may impact business expectations.
- Ensure compliance maintain market approvals.
- Liaise external consular services agents coordinate arrange notary apostille legalization required.
- Support business implementation execution comprehensive intelligence system supporting services.
- Encourage improvement alignment processes across Affairs group foster thorough knowledge principles compliance policies throughout organization training mentorship
- Support base business activities such Monthly Reports master data management portal/listing information annual establishment reviews
- Identify support lead process improvement projects streamline current activities increase department efficiencies update enhancement creation new policies procedures maintenance existing procedures
-Supports compliance QSR ISO MDSAP CE worldwide requirements appropriate customer complaints audits training systems
-Regulatory review approval documents supporting QMS registrations
-Maintaining submission documents shared drive folders databases accurate complete timely manner ensure prompt access information
-General administration duties maintenance Operations mailbox raising purchase requisitions behalf team
Skills & Experience:
-Regulatory/Quality experience medical devices
-Experience dealing directly Notified Bodies authorities
-Preparation submission regional technical documentation supporting registrations multiple territories
-Continuous improvement mindset track record implementing improvements systems
-Experience requirements devices containing animal-derived materials preferred
-Experience requirements Devices Ancillary medicinal substance preferred
-Knowledge compliance key international standards ISO 13485 ISO 14971
Qualifications/Education:
Preferred Education:
-Life Science Degree equivalent RAPS Certification preferred
Travel Requirements:
There may be some business-related travel associated with this role dependent on project local market UK travel associated because some team members home-based face-to-face contact line manager peers may required attendance relevant training development events would required some destinations involve overnight stay(s).
Working Conditions:
This position hybrid minimum expectation travel office Deeside days every other week there may rare instances whereby employee may required work outside non-core hours/days due unexpected event crisis project timeline pressure occur within industry.
Our transformation will change your career for good. You'll be pushed think bigger aim excellence ideas heard supported bring them life challenges stretch yourself embrace opportunities could make biggest impact yet stepping outside comfort zone work that'll move you.
Beware scams online individuals claiming represent Convatec formal recruitment process required all opportunities prior any offer employment include interview confirmed official email address if receive suspicious approach social media text message email phone call about recruitment do disclose personal information pay fees whatsoever unsure please contact us at .
Equal Opportunities:
Convatec provides equal employment opportunities all current employees applicants employment policy means no one discriminated against race religion creed color national origin nationality citizenship ancestry sex age marital status physical mental disability affectional sexual orientation gender identity military veteran status genetic predisposing characteristics basis prohibited law.
Notice Agency Search Firm Representatives:
Convatec not accepting unsolicited resumes agencies search firms job posting Resumes submitted any employee third party agency search firm without valid written signed agreement become sole property No fee paid candidate hired result unsolicited referral Thank you.
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