The Regulatory Compliance Manager will serve as a designated representative for Dutch Ophthalmic, USA, Inc. for the facility and state licensure purposes.
Key Responsibilities:
- Serve as a Designated Representative for the facility, for state licensure purposes.
- Collaborate with the Quality Assurance team to implement and uphold product handling protocols, product recall procedures, and corrective actions when necessary.
- Manage, maintain and renew the required licenses and documentation for the distribution center, ensuring all certifications are current and readily available for audits.
- Monitor storage, handling, and distribution of products, including maintaining appropriate environmental conditions and ensuring product integrity.
- Conduct regular inventory checks and reconcile discrepancies if applicable.
- Manage and ensure all pharmaceutical and medical device distribution activities comply with local and international regulatory standards (e.g., GDP, FDA, EMA, EU MDR).
- Maintain accurate and up-to-date records as required by regulatory agencies and company policies.
- Provide support during regulatory inspections, audits, or inquiries.
- Coordinate with manufacturers (e.g., D.O.R.C.) for product updates, batch tracking, and recall information.
- Support New Drug Application if needed.
Skills, Know-How, and Experience:
- Minimum of 3 years’ verifiable full-time managerial or supervisory experience in a pharmacy or wholesale drug distributor licensed in at least one state, where the responsibilities included but were not limited to recordkeeping, storage, and shipment of prescription drugs.
- Licensed Pharmacist in the state of New Hampshire preferred.
- Highly preferred if applicant has direct experience serving as a Designated Representative for a drug wholesaler/manufacturer or wholesale distributor required.
- Applicant should have knowledge of federal statutes applicable to wholesale drug distribution.
- Highly preferred if applicant has knowledge of state statutes applicable to wholesale drug distribution; willingness to enhance knowledge in this area expected.
- Position requires on-site presence at the facility 5 days a week during normal business hours.
- Actively involved and aware of daily operations of the facility and to maintain a working knowledge of all facility operations.
- Some states may require a license exam.
- High school diploma (or GED) required.
Does DORC International make you happy?
Does working for you mean working together? Realizing surgical devices together that help to make people see again? With a hands-on and both legs on the ground mentality? Do you want to work for an organization where you get freedom and responsibility? Where you are fully stimulated to come up with new ideas? And where innovation, quality and technology are woven into the DNA? Then DORC International is the place for you.
Would you like to know more about working at DORC International? Then read on here.
What does DORC International have to offer you?
At DORC International, you play at top level. It is therefore only logical that we reward you as a top player. You can expect the following:
- Excellent insurance benefits, time off and holiday pay.
- Low-cost Medical (MVI covers 90% of the premium!)
- Employer paid Dental (MVI covers 100% of the premium!)
- Employer paid Life Insurance, AD&D, STD & LTD Insurance
- 401k with generous company match
- Generous Time Off + 10 paid holidays
- Additional voluntary insurance offered such as Accident and Cancer Insurance.
Did you know ...?
DORC, short for Dutch Ophthalmic Research Center, manufactures equipment, instruments and liquids used in eye surgery.
DORC is a ZEISS company, an internationally leading technology enterprise that develops, manufactures and sells highly innovative products and solutions in a variety of business fields, such as medical technology. As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities.
Will you be our new Regulatory Compliance Manager?
Are you up for this? Then apply directly via the Apply Now button! Do you still have questions? Please contact Eric Govaarts our Global Recruiter: e.govaarts@dorcglobal.com.
Dutch Ophthalmic USA provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.