Regulatory Affairs Specialist - System Specialits

The role:

The Regulatory Affairs Systems Specialist will support database maintenance for Regulatory Intelligence (RIR) and facilitate the Medical/Regulatory/Legal (MRL) and Claims review process. The individual will assist in maintaining process compliance and efficiency, including the initial assessment to ensure the materials submitted are ready to progress, and assigned to the appropriate reviewers.

Key Responsibilities:

• Support RIR, MRL and Claims processes
• Manage reviews and optimal tracking of RIR materials, promotional materials and claims during their life cycle
• Follow the MRL and Claims triage process to review material input to ensure appropriate reviewers are assigned and that material can be effectively reviewed.
• Interface with cross-functional teams and SMEs to coordinate and assist with the execution of RIR, MRL and claims submissions and reviews.
• As required, support the approval of user access requests, to ensure only trained employees can access the electronic workflow systems.
• Assist in performing data extraction, analysis to prepare for monthly reports out to leadership.
• Assist with preparation of system related presentations and training.
• Assist with Standards Review Committee, interfacing with SME’s and Process owners.
• Ensure compliance with Company SOPs and WIs.
• Ensure all RIR documentation is filed in accordance and in line with Regulatory Intelligence SOP and other applicable Quality SOPs.
• Provide feedback and input into new ways of working.

Skills & Experience:

• Working with MRL review and/or Standard Review committees is strongly preferred.
• Demonstrable expertise in Compass or other applicable MRL software strongly preferred.
• Proficiency in Microsoft Office applications (Excel, Word, PowerPoint), and Adobe Acrobat.
• Familiarity with online based review and/or Regulatory software, is preferred.
• Continuous improvement mindset.
• Experience with proofreading complex documents.
• Experience of working in a regulated industry and quality management.
• Demonstrate strong organizational skills, including the ability to prioritize workload
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing, and commercial.

Qualifications/Education:

• University Degree (or equivalent)

Team

Part of a small project team. No direct reports. Indirect reports may include project resources.

Reporting to Senior Manager – International Regulatory Affairs, additional direction from Global Regulatory Program Director and Sr. Director, Regulatory Affairs Ostomy Care and Continence Care.

Principal Contacts & Purpose of Contact

Primary contact will be with SME’s associated with RIR, MRL and Claims submissions and reviews, and will include among others R&D, Marketing, Regulatory, Medical, and Legal colleagues across the globe.

Travel Requirements

Position may involve travel up to 10% of the time, mostly within Europe. Most trips will include overnight travel.

Whilst role is remote, regular travel to Convatec Technology Centre Deeside will be required to support face-to-face meetings.

Languages

Speaking: Yes English

Writing/Reading: Yes English

Additional languages are nice to have.

Working Conditions (Applicable local workplace laws and statutes should be included in the description of working conditions)

Remote working.

Hybrid working encouraged at a Convatec Technology Centre, an office environment.

Special Factors

Flexibility in working hours required due to time zones of other project team members.

Our transformation will change your career. For good. You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life. There’ll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet. This is stepping outside of your comfort zone.

This is work that’ll move you.

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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